NOVEMBER 2006
WEEK ENDING NOVEMBER 4
PRODUCT Lidocaine HCI Injection,
USP, 1%, 10 mg/ml, 30 mL single dose vial, NDC 0409-4279-02,
CODE
Lots: 39-467-DK, exp. 3/1/08; 41-243-DK, exp.
5/1/08
RECALLING FIRM/MANUFACTURER Hospira, Inc., Rocky Mount, NC
REASON
Product may contain particulates.
VOLUME OF
PRODUCT IN COMMERCE 292,600/30 mL
vials
DISTRIBUTION Nationwide
PRODUCT
1) PREDNISONE 1mg TABLET,
250 count bags (NDC 61392-642-25) & 30 count boxes (NDC 61392-642-30), Rx only,
2) PREDNISONE 2.5mg TABLET, 250 count bags
(NDC 61392-765-25) & 30 count boxes (NDC 61392-765-30), Rx only,
3) PREDNISONE 20mg TABLET, 250 count bags
(NDC
61392-418-25) & 30 count boxes (NDC 61392-418-30), Rx only,
4) PREDNISONE 5mg TABLET, 250 count bags
(NDC 61392-408-25)
& 30 count boxes (NDC 61392-408-30), Rx only,
5)
PRIMIDONE 250mg TABLET, 250 count bags (NDC 61392-024-25) & 30 count
boxes (NDC 61392-024-30), Rx only,
6) PRIMIDONE 50mg
TABLET, 250 count bags (NDC 61392-585-25) & 30 count boxes (NDC
61392-585-30), Rx only,
7) PROCHLORPERAZINE 10mg
TABLET, 250 count bags (NDC 61392-988-25) & 30 count boxes (NDC
61392-988-30), Rx only,
8) PROCHLORPERAZINE 5mg TABLET,
250 count bags (NDC 61392-467-25) & 30 count boxes (NDC 61392-467-30), Rx only,
9) PROMETHAZINE 25mg TABLET, 250 count bags
(NDC 61392-745-25) & 30 count boxes (NDC 61392-745-30), Rx only,
10) PROPAFENONE 150mg TABLET, 250 count bags
(NDC
61392-770-25) & 30 count boxes (NDC 61392-770-30), Rx only,
11) PROPRANOLOL 10mg TABLET, 250 count bags
(NDC 61392-420-25)
& 30 count boxes (NDC 61392-420-30), Rx only,
12)
PROPRANOLOL 20mg TABLET, 250 count bags (NDC 61392-423-25), 30 count boxes (NDC 61392-423-30) &
60 count boxes (NDC 61392-423-60), Rx only,
13) PROPRANOLOL 40mg TABLET, 250 count bags
(NDC
61392-430-25), 30 count boxes (NDC 61392-430-30) & 60 count boxes (NDC
61392-430-60), Rx only,
14) PROPRANOLOL 80mg TABLET, 250
count bags (NDC 61392-433-25) & 30 count boxes (NDC 61392-433-30), Rx only,
15) PROPYLTHIOURACIL 50mg TABLET, 250 count
bags (NDC 61392-468-25), 30 count boxes (NDC 61392-468-30), 60 count
boxes (NDC 61392-468-60), & 90 count boxes (NDC 61392-468-90), Rx only,
16) PSEUDOPHEDRINE 30mg TABLET (c), 250 count bags
(NDC
61392-007-25), 30 count boxes (NDC 61392-007-30), 60 count boxes (NDC
61392-007-60) & 90 count boxes (NDC 61392-007-90),
17) PSEUDOEPHEDRINE 60mg TABLET (c), 250 count bags
(NDC
61392-505-25), 30 count boxes (NDC 61392-505-30), 60 count boxes (NDC
61392-505-60), & 90 count boxes (NDC 61392-505-90),
18) PYRIDOSTIGMINE 60 TABLET, 250 count bags
(NDC 61392-795-25)
&
30 count boxes (NDC 61392-795-30), Rx only,
19)
QUINAPRIL 10mg TABLET, 250 count bags (NDC 61392-454-25)
& 30 count
boxes (NDC 61392-454-30), Rx only,
20) QUINAPRIL 20mg
TABLET, 250 count bags (NDC 61392-474-25) &
30 count boxes (NDC
61392-474-30), Rx only,
21) QUINAPRIL 40mg TABLET, 250
count bags (NDC 61392-475-25) &
30 count boxes (NDC 61392-475-30), Rx
only,
22) QUINIDINE SULFATE 200mg TABLET, 30 count boxes (NDC 61392-953-30), Rx only,
23) QUININE SULFATE 260mg
TABLET, 250 count bags (NDC 61392-809-25), 30 count boxes (NDC 61392-809-30)
& 60 count boxes (NDC 61392-809-60), Rx only, 24)
QUININE SULFATE 325mg CAPSULE, 250 count bags (NDC 61392-989-25)
& 30
count boxes (NDC 61392-989-30), Rx only,
25) RANITIDINE
150mg CAPSULE, 250 count bags (NDC 61392-086-25),
30 count boxes (NDC
61392-086-30) & 60 count boxes (NDC 61392-086-60), Rx only,
26) RANITIDINE 150mg TABLET, 250 count bags
(NDC 61392-836-25),
30 count boxes (NDC 61392-836-30) & 60 count boxes (NDC
61392-836-60), Rx only,
27) RANITIDINE 300mg CAPSULE, 250
count bags (NDC 61392-648-25) &
30 count boxes (NDC 61392-648-30), Rx
only,
28) RANITIDINE 300mg TABLET, 250 count bags (NDC
61392-837-25) &
30 count box (NDC 61392-837-30), Rx only,
29) RAZADYNE
(galantamine HBr) 12mg TABLET, 250 count bags
(NDC
61392-559-25) & 30 count boxes (NDC 61392-559-30), Rx only,
30) RAZADYNE
(galantamine HBr) 4mg TABLET, 250 count bags
(NDC
61392-555-25) & 30 count boxes (NDC 61392-555-30), Rx only,
31) REQUIP (ropinirole
HCl) 0.25mg TABLET, 250 count bags
(NDC
61392-323-25) & 30 count boxes (NDC 61392-323-30), Rx only,
32) REQUIP (ropinirole
HCl) 1mg TABLET, 250 count bags (NDC
61392-324-25) & 30 count boxes (NDC 61392-324-30), Rx only,
33) RIFAMPIN 300mg CAPSULE, 250 count bags
(NDC 61392-787-25) &
30 count boxes (NDC 61392-787-30), Rx only,
34)
SALSALATE 500mg TABLET, 250 count bags (NDC 61392-788-25) &
30 count
boxes (NDC 61392-788-30), Rx only,
35) SALSALATE 750mg
TABLET, 250 count bags (NDC 61392-814-25) &
30 count boxes (NDC
61392-814-30), Rx only,
36) SELEGILINE HYDROCHLORIDE 5mg
CAPSULE, 250 count bags
(NDC 61392-469-25) & 30 count boxes (NDC
61392-469-30), Rx only,
37) SENNA GEN 8.6mg TABLET, 250
count bags (NDC 61392-008-25),
30 count boxes (NDC 61392-008-30), & 60
count boxes (NDC 61392-008-60),
38) SENNA-S 50mg
TABLET, 30 count boxes (NDC 61392-703-30) &
60 count boxes (NDC
61392-703-60),
39) SKELAXIN 800mg TABLET, 250 count bags (NDC 61392-421-25) &
30 count boxes
(NDC 61392-421-30), Rx only,
40) SODIUM BICARBONATE 10GR TABLET, 250 count bags
(NDC
61392-643-25), 30 count boxes (NDC 61392-643-30) &
60 count boxes (NDC
61392-643-60),
41) SODIUM CHLORIDE 1gm TABLET, 250 count
bags (NDC 61392-508-25) &
30 count boxes (NDC 61392-508-30),
42) SOTALOL HCl 80mg TABLET, 250 count bags
(NDC 61392-999-25),
30 count boxes (NDC 61392-999-30), & 60 count boxes (NDC
61392-999-60), Rx only,
43) SPIRONOLACTONE 100mg TABLET,
250 count bags (NDC 61392-501-25) &
30 count boxes (NDC 61392-501-30),
Rx only,
44) SPIRONOLACTONE 25mg TABLET, 250 count bags (NDC 61392-083-25)
& 30 count boxes
(NDC 61392-083-30), Rx only,
45) SPIRONOLACTONE 50mg TABLET, 250 count bags
(NDC 61392-563-25)
& 30 count boxes (NDC 61392-563-30), Rx only,
46)
SPIRONOLACTONE and Hydrochlorothiazide 25mg/25mg TABLET,
250 count bags (NDC
61392-076-25) & 30 count boxes (NDC 61392-076-30),
Rx only,
47) STARLIX 120mg TABLET, 250 count bags
(NDC 61392-326-25) &
30 count boxes (NDC 61392-326-30), Rx only,
48)
SUCRALFATE 1gm TABLET, 250 count bags (NDC 61392-817-25),
30 count boxes (NDC 61392-817-30) & 60 count boxes
(NDC 61392-817-60),
Rx only,
49) SULFAMETHOXAZOLE/TRIMETHOPRIM 800mg/160mg, 250 count bags
(NDC 61392-947-25) & 30 count boxes (NDC 61392-947-30), Rx only,
50) SULINDAC 150mg TABLET, 250 count bags (NDC
61392-954-25)
& 30 count boxes (NDC 61392-954-30), Rx only,
51) TEGRETOL XR 400mg TABLET, 250 count bags
(NDC 61392-329-25),
Rx only,
52) TERAZOSIN 10mg CAPSULE, 250 count bags (NDC 61392-946-25) &
30 count boxes
(NDC 61392-946-30), Rx only,
53) TERAZOSIN 1mg CAPSULE, 250 count bags
(NDC 61392-943-25) &
30 count boxes (NDC 61392-943-30), Rx only,
54)
TERAZOSIN 2mg CAPSULE, 30 count boxes (NDC 61392-944-30) &
60 count
boxes (NDC 61392-944-60), Rx only,
55) TERAZOSIN 5mg
CAPSULE, 250 count bags (NDC 61392-945-25) &
30 count boxes (NDC
61392-945-30), Rx only,
56) TETRACYCLINE 250mg CAPSULE, 250
count bags (NDC 61392-789-25)
& 30 count boxes (NDC 61392-789-30), Rx
only,
57) TETRACYCLINE 500mg CAPSULE, 250 count bags (NDC
61392-771-25)
& 30 count boxes (NDC 61392-771-30), Rx only,
58) THEOPHYLLINE ER 100mg TABLET, 250 count bags
(NDC 61392-152-25)
&
30 count boxes (NDC 61392-152-30), Rx only,
59)
THEOPHYLLINE ER 200mg TABLET, 250 count bags (NDC 61392-016-25) &
30
count boxes (NDC 61392-016-30), Rx only,
60) THEOPHYLLINE
ER 300mg TABLET, 250 count bags (NDC 61392-017-25) &
30 count boxes (NDC
61392-017-30), Rx only,
61) THIORIDAZINE HCL100mg TABLET,
250 count bags (NDC 61392-144-25 &
30 count boxes (NDC 61392-144-30),
62) THIORIDAZINE 25mg TABLET, 250 count bags
(NDC
61392-463-25) &
30 count boxes (NDC 61392-463-30), Rx only,
63) THIORIDAZINE 50mg TABLET, 250 count bags
(NDC 61392-819-25)
&
30 count boxes (NDC 61392-819-30), Rx only,
64)
THIOTHIXENE 10mg CAPSULE, 250 count bags (NDC 61392-800-25),
30 count boxes
(NDC 61392-800-30) & 60 count boxes (NDC 61392-800-60),
Rx only,
65) THIOTHIXENE 5mg CAPSULE, 250 count bags
(NDC 61392-175-25),
30 count boxes (NDC 61392-175-30) & 60 count boxes (NDC
61392-175-60), Rx only,
66) TIZANIDINE 2mg TABLET, 250
count bags (NDC 61392-564-25) &
30 count boxes (NDC 61392-564-30), Rx
only,
67) TOPROL-XL (metoprolol succinate ER) 50mg TABLET,
250 count bags
(NDC 61392-410-25) & 30 count boxes (NDC 61392-410-30),
Rx only,
68) TORSEMIDE 10mg TABLET, 250 count bags (NDC
61392-780-25)
& 30 count boxes (NDC 61392-780-30), Rx only,
69) TORSEMIDE 20mg TABLET, 250 count bags
(NDC 61392-411-25)
& 30 count boxes (NDC 61392-411-30), Rx only,
70)
TRAMADOL HYDROCHLORIDE 50mg TABLET, 250 count bags
(NDC 61392-444-25), 30
count boxes (NDC 61392-444-30), & 60 count
boxes (NDC 61392-444-60), Rx
only,
71) TRAMADOL/APAP 37.5/325mg TABLET, 250 count bags (NDC 61392-497-25)
& 30 count boxes
(NDC 61392-497-30), Rx only,
72) TRAZODONE HYDROCHLORIDE 100mg TABLET, 250 count bags
(NDC
61392-490-25), 30 count boxes (NDC 61392-490-30) & 60 count
boxes (NDC
61392-490-60), Rx only,
73) TRAZODONE 150mg TABLET, 250
count bags (NDC 61392-179-25)
& 30 count boxes (NDC 61392-179-30), Rx
only, ;
74) TRAZODONE 50mg TABLET, 250 count bags (NDC
61392-487-25)
& 30 count boxes (NDC 61392-487-30), Rx only,
75)
TRIAMTERENE/HYDROCHLOROTHIAZIDE 37.5/25mg CAPSULE,
250 count
bags (NDC 61392-718-25), 30 count boxes (NDC 61392-718-30)
& 60 count
boxes (NDC 61392-718-60), Rx only,
76) TRIAMTERENE/HYDROCHLOROTHIAZODE 37.5/25mg TABLET,
250 count bags
(NDC
61392-829-25) & 30 count boxes (NDC 61392-829-30),
Rx only,
77) TRIFLUOPERAZINE 2mg TABLET, 250 count bags
(NDC 61392-822-25)
& 30 count boxes (NDC 61392-822-30), Rx only,
78)
TRIHEXYPHENIDYL 2mg TABLET, 250 count bags (NDC 61392-634-25)
& 30 count
boxes (NDC 61392-634-30), Rx only,
79) TRIHEXYPHENIDYL 5mg
TABLET, 250 count bags (NDC #61392095625)
& 30 count boxes (NDC
#61392095630), Rx only,
80) TRILEPTAL 150mg TABLET, 250
count bags (NDC 61392-554-25)
& 30 count boxes (NDC 61392-554-30), Rx
only,
81) TRIMETHOPRIM 100mg TABLET, 250 count bags (NDC
61392-793-25)
& 30 count boxes (NDC 61392-793-30), Rx only,
82) URSODIOL 300mg CAPSULE, 250 count bags
(NDC 61392-790-25)
& 30 count boxes (NDC 61392-790-30), Rx only,
83)
VALPROIC ACID 250mg CAPSULE, 250 count bags (NDC 61392-823-25)
& 30
count boxes (NDC 61392-823-30), Rx only,
84) VERAPAMIL
120mg TABLET, 250 count bags (NDC 61392-496-25)
& 30 count boxes (NDC
61392-496-30), Rx only,
85) VERAPAMIL 40mg TABLET, 250
count bags (NDC 61392-492-25)
& 30 count boxes (NDC 61392-492-30), Rx
only,
86) VERAPAMIL 80mg TABLET, 250 count bags (NDC
61392-493-25)
& 30 count boxes (NDC 61392-493-30), Rx only,
87) VERAPAMIL ER 180mg TABLET, 250 count bags
(NDC 61392-345-25)
& 30 count boxes (NDC 61392-345-30), Rx only,
88)
VERAPAMIL SR 120mg TABLET, 250 count bags (NDC 61392-791-25)
& 30 count
boxes (NDC 61392-791-30), Rx only,
89) WARFARIN 10mg
TABLET, 250 count bags (NDC 61392-909-25)
& 30 count boxes (NDC
61392-909-30), Rx only,
90) WARFARIN 1mg TABLET, 250 count
bags (NDC 61392-903-25)
& 30 count boxes (NDC 61392-903-30), Rx only,
91) WARFARIN 1mg TABLET, 250 count bags
(NDC 61392-903-25)
& 30 count boxes (NDC 61392-903-30), Rx only,
92)
WARFARIN 2.5mg TABLET, 250 count bags (NDC 61392-905-25)
& 30 count
boxes (NDC 61392-905-30), Rx only,
93) WARFARIN 2mg TABLET,
250 count bags (NDC 61392-904-25)
& 30 count boxes (NDC 61392-904-30),
Rx only,
94) WARFARIN 3mg TABLET, 250 count bags (NDC
61392-920-25)
& 30 count boxes (NDC 61392-920-30), Rx only,
95) WARFARIN 4mg TABLET, 250 count bags
(NDC 61392-906-25)
&
30 count boxes (NDC 61392-906-30), Rx only,
96) WARFARIN
5mg TABLET, 250 count boxes (NDC 61392-907-25)
& 30 count boxes (NDC
61392-907-30), Rx only,
97) WARFARIN 6mg TABLET, 250 count
bags (NDC 61392-911-25)
& 30 count boxes (NDC 61392-911-30), Rx only,
98) WARFARIN 7.5mg TABLET, 250 count bags
(NDC
61392-908-25) & 30 count boxes (NDC 61392-908-30), Rx only,
99) ZINC SULFATE 220mg CAPSULE, 250 count bags
(NDC
61392-824-25) & 30 count boxes (NDC 61392-824-30), Rx only,
100) ZONISAMIDE 100mg CAPSULE, 250 count bags
(NDC 61392-551-25)
& 30 count boxes (NDC 61392-551-30), Rx only,
101)
ZYRTEC 10mg TABLET, 250 count bags (NDC 61392-550-25)
& 30 count boxes (NDC 61392-550-30), Rx only,
CODE
1) K41718R25,
K42174R25, K42803R25, K43349R25, K41718R30,
K42174R30, K42803R30,
K43349R30;
2) K41227R25, K41719R25, K42175R25, K42799R25,
K43505R25,
K41227R30, K41719R30, K42175R30, K42799R30, K43505R30;
3)
K37054A25, K37054B25, K37397B25, K37769A25, K39086A25,
K36771A30, K37397A30,
K37769B30, K39086B30, K39464A30,
K39464B30, K41117A30;
4) K37168A25,
K37168B30, K42487A30, K40984A30;
5) K36717C25, K37875B25, K39082A25,
K40296B25, K40296C25,
K40837A25, K36717A30, K36717B30, K37875A30,
K37875C30,
K38696A30, K38696B30, K39169A30, K40114A30,
K40296A30,
K40296D30, K40837B30;
6) K36629R25, K36959R25, K37323R25,
K37662R25, K38091A25,
K40099A25, K40099B25, K40804A25, K36629R30,
K36959R30,
K37323R30, K37662R30, K38091A30, K38092A30,
K40416A30,
K40416B30, K40804B30;
7) K41641R25, K41919R25, K42294R25,
K42835R25, K41641R30,
K41919R30, K42294R30, K42835R30, K38819A30,
K38819B30,
K39475A30;
8) K41742R25, K41915R25, K42756R25, K43003R25,
K38504B25,
K41742R30, K41915R30, K42756R30, K43003R30,
K38504A30,
K38504C30, K38504D30, K39365A30, K39365B30, K39365C30;
9)
K42308R25, K40854R30, K42308R30, K43181R30;
10) K42245R25, K42924R25,
K42245R30, K42924R30;
11) K38595A25, K39545A25, K40889B25, K42583A25,
K38595B30,
K38595C30, K39239A30, K39239B30, K39545B30, K40414A30,
K40889A30, K41474A30;
12) K35975B25, K36233A25, K36390B25, K38183B25,
K38465A25,
K38465B25, K42909A25, K43071A25, K36233B30, K36390A30,
K38183A30, K38465C30, K38747A30, K39546A30, K39288A30,
K39288B30,
K35975A60;
13) K36116C25, K36116E25, K38270B25, K41531A25, K42582A25,
K36116B30, K36116D30, K37405A30, K37405B30, K37405C30,
K37405D30,
K38270A30, K38270C30, K41531B30, K41608A30,
K39402A30, K39402B30,
K36116A60;
14) K37582a25, K42942A25, K43193A25, K38969A25, K39951B25,
K40520A25, K41576A30, K38503A30, K38969B30, K38969C30,
K39951A30,
K40520B30;
15) K36317R25, K36632A25, K36943A25, K36943C25, K42712A25,
K38505A25, K39710B25, K36317R30, K36632A30, K36943B30,
K36943D30,
K37580A30, K37580B30, K37580C30, K38505B30,
K39710A30, K39710C30, K36317R60,
K36317R90;
16) K34517A25, K35250B25, K35899A25, K38056A25, K38056D25,
K40914B25, K35250A30, K35899C30, K41952A30, K37749A30,
K37749B30,
K38056C30, K38695A30, K38695B30, K39631A30,
K39768A30, K40431A30, K40914A30,
K34517B60, K35899A60,
K34517B90;
17) K35875R25, K36169A25, K41611A25,
K36691A25, K36691C25,
K38705B25, K35875R30, K36169A30, K41611B30, K36691B30,
K37408A30, K37408B30, K38705A30, K35875R60, K36169A60,
K35875R90,
K36169A90;
18) K40069R25, K40655R25, K41100A25, K40069R30,
K40655R30,
K41100A30;
19) K43409R25, K43409R30;
20) K43241R25, K43241R30;
21)
K43144R25, K43453R25, K43144R30, K43453R30;
22) K37466A30, K43316A30;
23)
K36299F25, K37756B25, K41657A25, K38371A25, K40181A25,
K36299C30, K36299D30,
K36299E30, K36299G30, K37756A30,
K37756C30, K41657B30, K38371B30, K38371C30,
K42684A30,
K39004A30, K39170A30, K39530A30, K40181B30, K40544A30,
K41041A30, K36299A60;
24) K41046A25, K41619A30, K39500A30,
K39500B30;
25) K39382R25, K39549R25, K39813R25, k40268r25, K35853C25,
K36068B25, K36294C25, K36355A25, K36355B25, K36430B25,
K36430X25,
K41469A25, K39813R30, K40268R30, K35853B30,
K36068A30, K36068C30, K36294B30,
K36430A30, K36430C30,
K36430D30, K41411R30, K35853A60, K35853D60,
K36294A60,
K36355C60, K36355D60;
26) K36160R25, K36536R25, K36899R25,
K37194A25, K37969B25,
K38456A25, K42486A25, K40270C25, K41131A25, K36160R30,
K36536R30, K36899R30, K37194A30, K37969A30, K37970A30,
K38253A30,
K39011A30, K41956A30, K42486B30, K42643A30,
K40270A30, K40270B30, K36160R60,
K36536R60, K36899R60,
K37194A60;
27) K41680R25, K42385R25, K43376R25,
K41680R30, K42386R30,
K42385R30, K43376R30;
28) K41228R25, K42011R25,
K42411R25, K42950R25, K43355R25,
K41228R30, K41888R30, K42011R30, K43229R30,
K43355R30;
29) K41643R25, K41976R25, K42300R25, K42937R25, K41643R30,
K41976R30, K42300R30, K42301R30, K42322R30, K42937R30;
30) K41642R25,
K42249R25, K42952R25, K41642R30, K42019R30,
K42249R30, K42952R30;
31)
K42113R25, K42290R25, K42954R25, K43411R25, K42113R30,
K42290R30, K42291R30,
K42954R30, K43411R30;
32) K42111R25, K42274R25, K42275R25, K42877R25,
K43468R25,
K42111R30, K42274R30, K42275R30, K42877R30, K43468R30;
33)
K40902R25, K41473R25, K42040R25, K42302R25, K43116R25,
K40902R30, K41473R30,
K42040R30, K42302R30, K43116R30;
34) K41478R25, K42039R25, K42777R25,
K42957R25, K41002R25,
K41478R30, K42039R30, K42777R30, K42957R30,
K41002R30;
35) K38139B25, K38443B25, K38139A30, K38139C30, K38443A30,
K38899A30, K38899B30, K40759A30;
36) K40662R25, K41097R25, K41864R25,
K42217R25, K40662R30,
K41097R30, K41864R30, K42217R30;
37) K35229A25,
K39824A25, K40010A30, K41059A60, K35639A60;
38) K36678R30, K36678R60;
39)
K42535R25, K42876R25, K43472R25, K42535R30, K42876R30,
K43472R30;
40)
K35520R25, K35763R25, K36088R25, K36445R25, K36746R25,
K37180R25, K35520R30,
K35763R30, K36088R30, K36445R30,
K36746R30, K37180R30, K35520R60, K35763R60,
K36088R60;
41) K43081R25, K43081R30;
42) K35346C25, K35346D25, K35346H25,
K35708A25, K36945A25,
K37089A25, K38377B25, K41598A25, K41136A25, K35346A30,
K35346F30, K35346G30, K35708B30, K36945B30, K38102A30,
K38377A30,
K38377C30, K39174A30, K40365A30, K41598B30,
K41136B30, K35346B60,
K35346E60;
43) K36502A25, K37065A25, K41610B25, K41713A25, K38351B25,
K38351E25, K40493B25, K40890B25, K36502A30, K37065A30,
K37065B30,
K41610A30, K38351A30, K38351C30, K38351D30,
K39724A30, K40493A30,
K40567A30;
44) K35644A25, K35644B25, K40321A30;
45) K41604A25, K39192R25,
K39653A25, K40782A25, K41604B30,
K42146B30, K39192R30, K39654R30, K39653A30,
K40782B30,
K41030A30;
46) K40996R25, K41925R25, K42576R25, K42822R25,
K41357R25,
K40996R30, K41925R30, K42576R30, K42822R30, K41357R30;
47)
K42722R25, K43059R25, K42722R30, K43059R30;
48) K36807B25, K36111A25,
K36354D25, K37415A25, K37415B25,
K41597A25, K38759B25, K38759C25, K40680B25,
K40788A25,
K40788C25, K36807A30, K36111C30, K36354B30, K36354C30,
K36354E30, K37415C30, K37415D30, K41597B30, K37819A30,
K37819B30,
K38433A30, K38433B30, K38677A30, K38677B30,
K38759A30, K38759D30, K39806A30,
K40680A30, K40788B30,
K35900A60, K36111B60;
49) K35348B25, K41660A25,
K36724C25, K42272A25, K42806A25,
K37414B25, K37414C25, K37734B25, K38506A25,
K38673B25,
K38673C25, K38673D25, K39168A25, k38942a25, K39681B25,
K40269A25, K40269B25, K40877B25, K40992B25, K41109A25,
K35348A30,
K35704A30, K35704B30, K35704C30, K36353A30,
K41660B30, K36724A30, K36724B30,
K36724D30, K37414A30,
K37734A30, K38673A30, K39534A30, K39681A30, K40877A30,
K40992A30;
50) K38043B25, K38935A25, K36696A30, K36696B30, K36696C30,
K37687A30, K37687B30, K38043A30, K38552A30, K38552B30,
K39860A30,
K40530A30, K40709A30, K41052A30;
51) K43219R25;
52) K37079A25, K38098A25,
K38905A25, K38905C25, K41360B25,
K36295A30, K37079B30, K37467A30, K38098B30,
K38381A30,
K38905B30, K39474A30, K41360A30;
53) K38335A25, K41539A25,
K39391A25, K39979B25, K38335B30,
K38856A30, K41539B30, K42468B30, K39391B30,
K39979A30,
K39979C30, K39979D30;
54) K35902B30, K37468A30, K38263A30,
K40375A30, K40375B30,
K39008A30, K39008B30, K43070A30, K40182A30,
K40879A30,
K40879B30, K35902A60;
55) K37478A25, K38551B25, K38551C25,
K37478B30, K41605A30,
K41606B30, K38551A30, K39369A30;
56) K42554A25,
K39333R25, K39656A25, K42554B30, K39333R30,
K39656A30;
57) K42471A25,
K37640R25, K38236R25, K39165R25, K39532B25,
K41573A30, K37640R30, K38236R30,
K39165R30, K39531A30;
58) K36351C25, K37391A25, K37391B25, K41068B25,
K36351A30,
K36351B30, K38375A30, K38375B30, K38792A30, K39291A30,
K40467A30, K41068A30, K41068C30;
59) K36218A25, K36218B25, K36218D25,
K37877A25, K41543A25,
K39980A25, K36218C30, K37877B30, K38184A30, K39980B30,
K39981A30, K43063A30, K40878A30, K41069A30;
60) K36267A25, K36267B25,
K36801A25, K37876B25, K38594B25,
K38823A25, K38823B25, K42135A25, K42558A25,
K36801B30,
K36802A30, K37876A30, K38594A30, K42047A30, K42076A30,
K39241A30, K43282A30, K40787A30;
61) K42221R25, K43043R25, K43358R25,
K42221R30, K43043R30,
K43358R30;
62) K40661R25, K41309R25, K42080R25,
K42298R25, K42919R25,
K43408R25, K40661R30, K41309R30, K42080R30, K42298R30,
K42919R30, K43408R30;
63) K42408R25, K42795R25, K43354R25, K42408R30,
K42795R30,
K43354R30;
64) K34146A25, K35361B25, K36670D25, K42152A25,
K39005A25,
K41114A25, K41114C25, K34146A30, K35361A30, K36670A30,
K36670B30, K36670C30, K38159A30, K38159B30, K39005B30,
K39978A30,
K39978B30, K40925A30, K34146A60;
65) K34144A25, K42480A25, K37476A25,
K38280A25, K39006A25,
K41361A25, K34144A30, K37476B30, K43435A30, K38280B30,
K39006B30, K34144A60;
66) K42398R25, K42976R25, K42398R30,
K42976R30;
67) K42620R25, K40855R30;
68) K42021R25, K42236R25, K42815R25,
K43402R25, K42021R30,
K42236R30, K42815R30, K43402R30;
69) K41267R25,
K41895R25, K42338R25, K42549R25, K43084R25,
K41267R30, K41895R30, K41893R30,
K41894R30, K42338R30,
K42549R30, K43084R30;
70) K41093R25, K41358R25,
K41750R25, K43058R25, K43343R25,
K40813R30, K41093R30, K41750R30, K41856R30,
K42067R30,
K43058R30, K43343R30, K40813R60, K43058R60, K43343R60;
71)
K43044R25, K43044R30;
72) K40374A25, K40374C25, K37053A30, K37082A30,
K38072A30,
K39436A30, K40159A30, K40374B30, K35756A60;
73) K37296A25,
K37296B25, K38126B25, K39829A25, K40805A25,
K38126A, K38126C30, K38494A30,
K38494B30, K38771A30,
K38771B30, K39246A30, K39385A30, K40486A30,
K40805B30;
74) K37106A25, K37106B30, K39504A30;
75) K35605A25, K35605C25,
K35605D25, K42472A25, K39577A25,
K34194D30, K35605B30, K35605E30, K37454A30,
K43438A30,
K38093A30, K38794A30, K39686A30, K34194A60, K34194B60,
K34194C60;
76) K36761C25, K37074A25, K39529A25, K41083A25, K41083B25,
K41363A25, K36761A30, K36761B30, K37074B30, K41033A30,
K41083C30,
K41363B30;
77) K39619A25, K39619B25, K40899B25, K38046A30, K38046B30,
K39404A30, K40899A30, K40899C30, K40899D30;
78) K38083B25, K38352A25,
K40526A25, K37059A30, K37762A30,
K38083A30, K38352B30, K38904A30, K39465A30,
K40784A30;
79) K42150A25, K40156A25, K40156B25, K37481A30, K37481B30,
K37481C30, K37481D30, K41135A30, K39461A30, K40156C30;
80) K41512R25,
K41918R25, K42201R25, K43079R25, K41512R30,
K41918R30, K42201R30,
K43079R30;
81) K41557R25, K42036R25, K42303R25, K43236R25, K41557R30,
K42036R25, K42037R30, K42303R30, K43236R30;
82) K41410R25, K42020R25,
K42573R25, K42814R25, K43403R25,
K41410R30, K42020R30, K42573R30, K42814R30,
K43403R30;
83) K37099A25, K37099C25, K37757B25, K37757C25, K41601A25,
K41601X25, K41716A25, K42571A25, K39501A25, K39501B25,
K39929A25,
K40858A25, K37099B30, K37757A30, K37757D30,
K41601B30, K39929B30, K39929C30,
K40858B30;
84) K38451A25, K38704B25, K38451A30, K41661A30, K38704A30,
K38704C30, K40297A30;
85) K41553R25, K42034R25, K42310R25, K43137A25,
K39838R25,
K40649R25, K41553R30, K42034R30, K42310R30, K43137R30,
K39838R30, K40649R30;
86) K37469R25, K38450A25, K41138B25, K37469R30,
K38450A30,
K38799A30, K38799B30, K41138B30, K41138C30;
87) K41899R25,
K42216R25, K42891R25, K43359R25, K41899R30,
K42216R30, K42891R30, K43359R30;
88) K42038R25, K42813R25, K42639R25, K42038R30, K42813R30,
K42639R30;
89) K35010A25, K35703A25, K36422A25, K36422C25, K36766B25,
K41617A25, K41618B25, K38436B25, K39473A25, K34499A30,
K35010B30,
K35703B30, K36422B30, K36422D30, K36766A30,
K36766C30, K38034A30, K38034B30,
K38436A30, K38436C30,
K38936A30, K38936B30, K40318A30;
90) K38829B25,
K38829C25, K37450A30, K38829A30, K40929A30,
K41134A30;
91) K38829B25,
K38829C25, K37450A30, K38829A30, K40929A30,
K41134A30;
92) K36364C25,
K37069B25, K36364A30, K36364B30, K36814A30,
K36814B30, K37069A30, K37069C30,
K38580A30, K39393A30;
93) K35380A25, K36767A30, K36767B30, K36767C30;
94)
K37448B25, K41027A25, K37078A30, K37448A30,
K42269A30, K39701A30,
K40354A30;
95) K34510A25, K35368A25, K37075A30, K42179A30;
96) K37076A25,
K38606A25, K42547A30;
97) K42168A25, K42180A25, K37449B25, K40468A25,
K40880A25,
K37077A30, K42180B30, K37449A30, K40468B30, K40880B30,
K41113A30;
98) K39625B25, K41616A30, K39625A30;
99) K36762A25,
K36762B30, K41538A30, K42081A30;
100) K41725R25, K42197R25, K43244R25,
K41725R30,
K42197R30, K43244R30;
101) K42014R25, K42311R25, K42445R25,
K42878R25,
42014R30, K42013R30, K42311R30, K42445R30,
K42878R30
RECALLING FIRM/MANUFACTURER Heartland Repack Services, LLC, Toledo, OH,
REASON
Mispacked; possibility of a product package
mix-up.
VOLUME OF PRODUCT IN COMMERCE 411,677
units
DISTRIBUTION Nationwide
PRODUCT
Esmolol Hydrochloride
Injection, 100 mg/10mL (10 mg/mL), 10 mL single dose vial, Rx only, NDC
63323-652-10,
CODE Lot: 402505, exp.
06/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis
Pharmaceutical Products, Rosemont, IL,
Manufacturer: Abraxis Pharmaceutical Products, Grand Island, NY.
REASON
Failed total impurity
specification.
VOLUME OF PRODUCT IN COMMERCE 17,425
vials
DISTRIBUTION Nationwide and PR
WEEK ENDING NOVEMBER 11
PRODUCT ISOSORBIDE MONONITRATE
10mg TABLET, 250 count bags (NDC 61392-912-25) & 30 count boxes (NDC
61392-912-30), Rx only,
ISOSORBIDE MONONITRATE 120mg
TABLET, 250 count bags (NDC 61392-538-25) & 30 count boxes (NDC
61392-538-30), Rx only,
ISOSORBIDE MONONITRATE 20mg
TABLET, 250 count bags (NDC 61392-913-25) & 30 count boxes (NDC
61392-913-30), Rx only,
ISOSORBIDE MONONITRATE ER 30mg
TABLET, 250 count bags (NDC 61392-916-25) & 30 count boxes (NDC
61392-916-30), Rx only,
ISOSORBIDE MONONITRATE ER 60mg
TABLET, 250 count bags (NDC 61392-917-25) & 30 count boxes (NDC
61392-917-30), Rx only,
KLOR-CON M10, Potassium Chloride E.R., 10 mEq TABLET, 250 count bags
(NDC 61392-689-25), 30 count boxes (NDC
61392-689-30) & 60 count boxes (NDC 61392-689-60), Rx only,
KLOR-CON M20, Potassium Chloride
E.R., 20mEq TABLET, 250 count bags (NDC 61392-690-25) & 30 count boxes (NDC 61392-690-30), Rx only,
K-TAB, potassium chloride ER, 10mEq (750mg) TABLET, 60 count boxes
(NDC 61392-900-60), Rx only,
LABETALOL HYDROCHLORIDE, 100mg
TABLET, 250 count bags (NDC 61392-459-25) & 30 count boxes (NDC
61392-459-30), Rx only,
LABETALOL HYDROCHLORIDE 300mg
TABLET, 250 count bags (NDC 61392-776-25) & 30 count boxes (NDC
61392-776-30), Rx only,
LAMICTAL (LAMOTRIGINE) 100mg
TABLET, 250 count bags (NDC 61392-556-25) & 30 count boxes (NDC
61392-556-30), Rx only,
LEXAPRO (escitalopram oxalate) 20mg
TABLET, 30 count boxes (NDC 61392-785-30), Rx only,
LEXAPRO (escitalopram oxalate) 5mg TABLET, 250 count bags
(NDC 61392-322-25) & 30
count boxes (NDC 61392-322-30), Rx only,
LISINOPRIL 10mg
TABLET, 250 count bags (NDC 61392-693-25) & 30 count boxes (NDC
61392-693-30), Rx only,
LISINOPRIL 2.5mg TABLET, 30 count
boxes (NDC 61392-691-30), Rx only,
LISINOPRIL 20mg TABLET,
30 count boxes (NDC 61392-694-30), Rx only,
LISINOPRIL 30mg
TABLET, 250 count bags (NDC 61392-695-25) & 30 count boxes (NDC
61392-695-30), Rx only,
LISINOPRIL 40mg TABLET, 250 count
bags (NDC 61392-696-25), 30 count boxes (NDC 61392-696-30) & 60 count boxes
(NDC 61392-696-60), Rx only,
LISINOPRIL/HYDROCHLOROTHIAZIDE
10mg/12.5mg TABLET, 250 count bags (NDC 61392-697-25) & 30 count boxes (NDC
61392-697-30), Rx only,
LISINOPRIL/HYDROCHLORIOTHIAZIDE
20mg/12.5mg TABLET, 250 count bags (NDC 61392-698-25) & 30 count boxes (NDC
61392-698-30), Rx only,
LITHIUM CARBONATE 150mg CAPSULE,
250 count bags (NDC 61392-539-25) & 30 count boxes (NDC 61392-539-30), Rx
only,
LITHIUM CARBONATE 300mg CAPSULE, 250 count bags (NDC
61392-131-25) & 30 count boxes (NDC 61392-131-30), Rx only,
LITHIUM CARBONATE ER 300mg TABLET, 250 count bags
(NDC 61392-736-25)
& 30 count boxes (NDC 61392-736-30), Rx only,
LOPERAMIDE HYDROCHLORIDE 2mg CAPSULE, 250 count bags
(NDC
61392-336-25) & 30 count boxes (NDC 61392-336-30), Rx only,
LORATADINE 10mg TABLET, 250 count bags
(NDC 61392-562-25) & 30
count boxes (NDC 61392-562-30), Rx only,
LOVASTATIN 10mg
TABLET, 250 count bags (NDC 61392-797-25) & 30 count boxes (NDC
61392-797-30), Rx only,
MECLIZINE HYDROCHLORIDE 12.5MG
TABLET, 250 count bags (NDC 61392-338-25), 30 count boxes (NDC 61392-338-30)
& 90 count boxes (NDC 61392-338-90), Rx only,
MECLIZINE
HYDROCHLORIDE 25mg TABLET, 250 count bags (NDC 61392-339-25), 30 count boxes (NDC 61392-339-30), & 60 count boxes
(NDC 61392-339-60), Rx only,
METFORMIN HYDROCHLORIDE 1000mg TABLET, 250 count bags
(NDC
61392-687-25) & 30 count boxes (NDC 61392-687- 30), Rx only,
METFORMIN HYDROCHLORIDE 500mg TABLET, 250 count bags
(NDC
61392-685-25), 30 count boxes (NDC 61392-685-30), & 60 count boxes (NDC
61392-685-60), Rx only,
METFORMIN HYDROCHLORIDE 850mg
TABLET, 250 count bags (NDC 61392-686-25) & 30 count boxes (NDC 61392-686-
30), Rx only,
METFORMIN HYDROCHLORIDE ER 500mg TABLET, 250
count bags (NDC 61392-419-25) & 30 count boxes (NDC 61392-419-30), Rx only,
METHAZOLAMIDE 50mg TABLET, 30 count boxes
(NDC
61392-890-30), Rx only, METHIMAZOLE 10mg TABLET, 250 count
bags (NDC 61392-450-25) & 30 count boxes (NDC 61392-450-30), Rx only,
METHIMAZOLE 5mg TABLET, 250 count bags
(NDC 61392-571-25), &
30 count boxes (NDC 61392-571-30), Rx only,
METHOCARBAMOL
500mg TABLET, 250 count bags (NDC 61392-460-25), 30 count boxes (NDC
61392-460-30) & 60 count boxes (NDC 61392-460-60), Rx only, METHOCARBAMOL 750mg TABLET, 250 count bags
(NDC 61392-773-25) &
30 count boxes (NDC 61392-773-30), Rx only,
METHYLDOPA
250mg TABLET, 250 count bags (NDC 61392-184-25), 30 count boxes (NDC
61392-184-30) & 60 count boxes (NDC 61392-184-60), Rx only,
METOCLOPRAMIDE 10mg TABLET, 60 count boxes
(NDC 61392-558-60) &
90 count boxes (NDC 61392-558-90), Rx only,
METOCLOPRAMIDE
5mg TABLET, 250 count bags (NDC 61392-557-25) & 30 count boxes (NDC
61392-557-30), Rx only,
METOPROLOL TARTRATE 100mg TABLET,
250 count bags (NDC 61392-280-25), 30 count boxes (NDC 61392-280-30) & 60
count boxes (NDC 61392-280-60), Rx only,
METOPROLOL
TARTRATE 25mg TABLET, 250 count bags (NDC 61392-285-25), 30 count boxes (NDC
61392-285-30) & 60 count boxes (NDC 61392-285-60), Rx only,
METOPROLOL TARTRATE 50mg TABLET, 30 count boxes
(NDC 61392-286-30)
& 60 count boxes (NDC 61392-286-60), Rx only,
METRONIDAZOLE 250mg TABLET, 250 count bags
(NDC 61392-397-25), 30
count boxes (NDC 61392-397-30), & 60 count boxes (NDC 61392-397-60), Rx
only, 45) METRONIDAZOLE 500mg TABLET, 250 count bags (NDC
61392-399-25), 30 count boxes (NDC 61392-399-30) & 60 count boxes (NDC
61392-399-60), Rx only, MIDODRINE 2.5mg TABLET, 250 count
bags (NDC 61392-816-25) & 30 count boxes (NDC 61392-816-30), Rx only,
MINOXIDIL 2.5mg TABLET, 250 count bags
(NDC 61392-461-25), 30
count boxes (NDC 61392-461-30), 60 count boxes (NDC 61392-461-60) & 90 count
boxes (NDC 61392-461-90), Rx only,
MIRTAZAPINE 15mg TABLET,
250 count bags (NDC 61392-456-25) & 30 count boxes (NDC 61392-456-30), Rx
only,
MIRTAZAPINE 30MG TABLET, 250 count bags (NDC
61392-457-25) & 30 count boxes (NDC 61392-457-30), Rx only,
MIRTAZAPINE 7.5mg TABLET, 250 count bags
(NDC 61392-451-25) & 30
count boxes (NDC 61392-451-30), Rx only,
MUCINEX 600mg
TABLET, 250 count bags (NDC 61392-483-25), & 30 count boxes (NDC
61392-483-30),
NABUMETONE 750mg TABLET, 250 count bags (NDC
61392-772-25) & 30 count boxes (NDC 61392-772-30), Rx only,
NALTREXONE 50mg TABLET, 250 count bags
(NDC 61392-466-25), 30 count
boxes (NDC 61392-466-30) & 60 count boxes (NDC 61392-466-60), Rx only,
NAPROXEN 250mg TABLET, 250 count bags
(NDC 61392-289-25)
& 30 count boxes (NDC 61392-289-30), Rx only,
NAPROXEN
375mg TABLET, 250 count bags (NDC 61392-292-25), 30 count boxes (NDC
61392-292-30) & 60 count boxes (NDC 61392-292-60), Rx only,
NAPROXEN 500mg TABLET, 250 count bags
(NDC 61392-295-25) & 30
count boxes (NDC 61392-295-30), Rx only,
NIFEDIAC ER 30mg
TABLET, 250 count bags (NDC 61392-484-25) & 30 count boxes (NDC
61392-484-30), Rx only,
NIFEDIAC ER 60mg TABLET, 250 count
bags (NDC 61392-485-25) & 30 count boxes (NDC 61392-485-30), Rx only,
NIFEDIAC ER 90mg TABLET, 250 count bags
(NDC 61392-486-25) &
30 count boxes (NDC 61392-486-30), Rx only, ;
NIFEDIPINE 10mg
CAPSULE, 250 count bags (NDC 61392-356-25), 30 count boxes (NDC 61392-356-30)
& 60 count boxes (NDC 61392-356-60), Rx only,
NIFEDIPINE ER 30mg TABLET, 250 count bags
(NDC 61392-995-25) &
30 count boxes (NDC 61392-995-30), Rx only,
NIFEDIPINE ER
60mg TABLET, 250 count bags (NDC 61392-645-25) & 30 count boxes (NDC
61392-645-30), Rx only,
NIFEDIPINE ER 90mg TABLET, 250
count bags (NDC 61392-646-25) & 30 count boxes (NDC 61392-646-30), Rx only,
NITROFURANTOIN 50mg CAPSULE, 30 count boxes
(NDC
61392-639-30), Rx only,
NITROFURANTOIN MACR 100mg CAPSULE,
30 count boxes (NDC 61392-734-30), Rx only,
NITROFURANTOIN
MACR 50mg CAPSULE, 250 count bags (NDC 61392-639-25), Rx only,
NITROFURANTOIN MONOHYDRATE 100mg CAPSULE, 250 count bags
(NDC
61392-494-25) & 30 count boxes (NDC 61392-494-30), Rx only,
NITROGLYCERIN EXTENDED RELEASE 2.5mg CAPSULE , 250 count bags
(NDC
61392-640-25) & 30 count boxes (NDC 61392-640-30), Rx only,
NITROGLYCERIN EXTENDED RELEASE, 6.5mg CAPSULE, 250 count bags
(NDC
61392-641-25) & 30 count boxes (NDC 61392-641-30), Rx only,
NORTRIPTYLINE 10mg CAPSULE, 250 count bags
(NDC 61392-361-25), 30
count boxes (NDC 61392-361-30), Rx only,
NORTRIPTYLINE 25mg
CAPSULE, 250 count bags (NDC 61392-364-25) & 30 count boxes (NDC
61392-364-30), Rx only,
NORTRIPTYLINE 50mg CAPSULE, 250
count bags (NDC 61392-367-25) & 30 count boxes (NDC 61392-367-0), Rx only,
NORVASC 5mg TABLET, 30 count boxes
(NDC 61392-711-30), Rx
only,
OXYBUTYNIN 5mg TABLET, 250 count bags (NDC
61392-138-25), 30 count boxes (NDC 61392-138-30), & 60 count boxes (NDC
61392-138-60), Rx only,
PAROXETINE 10mg TABLET, 250 count
bags (NDC 61392-404-25) & 30 count boxes (NDC 61392-404-30), Rx only,
PAROXETINE 30mg TABLET, 250 count bags
(NDC 61392-406-25) & 30
count boxes (NDC 61392-406-30), Rx only,
PAROXETINE 30mg
TABLET, 250 count bags (NDC 61392-406-25) & 30 count boxes (NDC
61392-406-30) Rx only,
PAROXETINE 40mg TABLET, 250 count
bags (NDC 61392-407-25) & 30 count boxes (NDC 61392-073-), Rx only,
PENTOXIFYLLINE 400mg ER TABLET, 250 count bags
(NDC 61392-833-25),
Rx only,
PERPHENAZINE 2mg TABLET, 250 count bags (NDC
61392-082-25) & 30 count boxes (NDC 61392-082-30), Rx only,
PERPHENAZINE 4mg TABLET, 250 count bags
(NDC 61392-081-25) & 30
count boxes (NDC 61392-081-30), Rx only,
PERPHENAZINE 8mg
TABLET, 30 count boxes (NDC 61392-084-30), Rx only, PHENYTOIN SODIUM 100mg CAPSULE, 250 count bags
(NDC 61392-937-25),
Rx only,
PLARETASE 8000mg TABLET, 250 count bags (NDC
61392-775-25) & 30 count boxes (NDC 61392-775-30), Rx only,
POTASSIUM CHLORIDE 10mEq CAPSULE, 250 count bags
(NDC 61392-402-25),
30 count boxes (NDC 61392-402-30) & 60 count boxes (NDC 61392-402-60), Rx
only,
POTASSIUM CHLORIDE ER 8mEq TABLET, 250 count bags (NDC 61392-403-25), 30 count boxes
(NDC 61392-403-30) & 60 count boxes (NDC
61392-403-60), Rx only,
PRAVASTATIN 20mg TABLET, 250 count
bags (NDC 61392-368-25) & 30 count boxes (NDC 61392-368-30), Rx only,
CODE
K38044A25, K38167C25, K41715A25, K42163A25,
K38167B25, K38044B30, K38167A30, K39017A30, K39017B30, K40433A30, K41155A30,
K41715B30;
K40648R25, K41098R25, K41806R25, K42172R25, K42801R25, K43383R25,
K40648R30, K41098R30, K41783R30, K41806R30, K42172R30, K42801R30,
K43383R30;
K38469A25, K40469A25, K41013A25, K38096A30, K38469B30, K38469C30,
K38881A30, K38881B30, K39973A30, K40469B30, K41013B30, K41154A30;
K40763R25,
K41112R25, K41913R25, K42176R25, K42838R25, K40763R30, K41112R30, K41913R30,
K42176R30, K42370R30, K42177R30, K42838R30;
K41162R25, K41914R25, K42499R25,
K42837R25, K41162R30, K41914R30, K42306R30, K42499R30, K42837R30;
K35533A25,
K36014A25, K36014C25, K35533B30, K36014B30, K36014D60;
K35904A25, K36290B25,
K37107B25, K37424B25, K38150B25, K41596A25, K42151A25, K42556A25, K42557A25,
K38385B25, K38901A25, K39711A25, K40528A25, K35347A30, K35680A30, K35904B30,
K36290A30, K36290C30, K36290D30, K36664A30, K36664B30, K36902A30, K36902B30,
K37108A30, K37107A30, K37107C30, K37424A30, K37424C30, K37825A30, K37825B30,
K38150A30, K41503A30, K41596B30, K41736A30, K41866A30, K42001A30, K42115A30,
K42151B30, K42195A30, K42196A30, K42556B30, K42557B30, K39711C30, K42941A30,
K38385A30, K38385C30, K38385D30, K38901B30, K38993A30, K38993B30, K36291D30,
K39711B30, K39797A30, K40166A30, K40367A30, K40367B30, K40367C30, K40528B30,
K40921A30, K41221A30;
K41014A60;
K36806B25, k38070A25, K38546B25,
K38996B25, K40521A25, K36806A30, K36806C30, K37406A30, K37581A30, K37581B30,
K637820a30, K38546A30, K38546C30, K42465A30, K38996A30, K38996C30;
K37275R25,
K37540R25, K41572A25, K38234R25, K38820A25, K37275R30, K37540R30, K41572B30,
K42118A30, K39509A30, K39509B30, K38234R30, K38820B30, K40898A30,
K41032A30;
K42114R25, K42321R25, K42938R25, K42114R30, K42321R30, K42336R30,
K42938R30;
K41795R30, K41999R30, K42498R30;
K42889R25, K42575R30,
K42889R30, K42888R30;
K42494A25, K37067A30;
K37066A30, K38341A30,
K38525A30, K40355A30;
K37062A30;
K36947A25, K38233A25, K38793B25,
K41857A25, K40922A25, K40922B25, K36947B30, K38793C30, K41857B30, K40223A30,
K40783A30, K40922C30;
K35614A25, K36420B25, K36420C25, K35614C30, K35614E30,
K36420A30, K36765A30, K36904B30, K35614D60, K36904A60;
K36901A25, K36901C25,
K38077B25, K41818A25, K40418A25, K36901B30, K36901D30, K38077A30, K38077C30,
K38549A30, K38549B30, K39695A30, K40418B30, K40608A30, K40608B30;
K36808A25,
K36808C25, K39950A25, K41288A25, K36404A30, K36808B30, K37462A30, K38078A30,
K38954A30, K39950B30, K41115A30, K41288B30;
K40934R25, K41356R25, K41745R25,
K42268R25, K43142R25, K43451R25, K40934R30, K40935R30, K41356R30, K41745R30,
K42268R30, K43142R30, K43451R30;
K40911R25, K41499R25, K41756R25, K42250R25,
K42977R25, K43380R25, K40911R30, K41499R30, K41756R30, K42250R30, K42977R30,
K43380R30;
K41476R25, K42056R25, K42396R25, K42638R25, K43233R25, K41476R30,
K42056R30, K42396R30, K43233R30;
K40918A25, K38593A30, K39866A30,
K40918B30;
K38090A25, K41823A30, K41535A30;
K40068R25, K40682R25,
K41101A25, K42148B30, K40068R30, K40682R30, K41101A30;
K35705A25, K35705C25,
K37402A25, K38185A25, K41530A25, K39893A25, K39893B25, K35705D30, K37402B30,
K38185B30, K41530B30, K42562A30, K35705B90;
K33936A25, K37401A25, K38976B25,
K33936A30, K37401B30, K38976D30, K39487A30, K40220A30, K40488A30, K33936A60,
K36772A60, K38976A60, K38976C60;
K34995A25, K34995B25, K36094A25, K36094C25,
K36583B25, K41422A25, K37570B25, K38516A25, K38866B25, K39352A25, K39974B25,
K40835B25, K35352A30, K35352B30, K36094B30, K36583A30, K36583C30, K36583D30,
K41422B30, K42121A30, K37570A30, K38055A30, K38055B30, K42963B30, K43028A30,
K38516B30, K38516C30, K38866A30, K39352B30, K39974A30, K39974C30, K39974D30,
K40835A30, K40835C30;
K37094a25, K38980A25, K37457A30, K39138A30, K36703A60,
K39138B60;
K34642A25, K34642B25, K35531A25, K36292B25, K36292C25, K36292E25,
K36292G25, K39720A25, K37755B25, K41502A25, K43192A25, K39823A25, K39823C25,
K40892A25, K41116A25, K34642A30, K34642C30, K35378A30, K35531B30, K36292A30,
K36292D30, K36292F30, K36292H30, K37072A30, K37755A30, K37755C30, K41502B30,
K38548A30, K38548B30, K38865A30, K39823B30, K39823D30, K40417A30,
K40892B30;
K36265A25, K36844B25, K36844C25, K38106B25, K38796A25, K39924A25,
K40834A25, K40834C25, K40834X25, K36265B30, K36844A30, K36844D30, K38106A30,
K38106C30, K38502A30, K38796B30, K39924B30, K40119A30, K40119B30, K40277A30,
K40277B30, K40834B30, K40834D30;
K36112A30, K36112B30, K36112C30, K38880A30,
K38880B30, K39873A30, K39873B30, K41040A30;
K43060R25,
K43060R30;
K36309A25, K41730A25, K38164B25, K39503A25, K40466A25, K42961A30,
K36309A30, K41536A30, K37088A30, K37088B30, K38164A30, K38164C30, K39503A30,
K40466B30;
K35079R25, K35829R25, K36521R25, K36880R25, K37187R25, K37523A25,
K41532A25, K38071A25, K35079R30, K35829R30, K36521R30, K36880R30, K37187R30,
K37523A30, K41532B30, K38538A30, K38538B30, K42699A30, K35079R60,
K35829R60;
K39194R25, K40470A25, K42545B30, K39194R30,
K40470B30;
K41577A25, K38773A25, K39655B25, K40977A25, K35357B30, K35357C30,
K41577B30, K38063A30, K38063B30, K38773B30, K39655A30, K39655D30, K40977B30,
K35357A60;
K41152A60, K42332A90;
K38032R25, K38032R30;
K35764R25,
K35764R30, K36804A30, K42333A30, K38609A30, K35764R60;
K37104A25, K42622A25,
K41865A30, K38675A30, K38169A60, K41224A60;
K39432A30, K40523B30, K35817R60,
K38148A60, K40523A60;
K36344R25, K36745R25, K37179R25, K37568A25, K39623A25,
K41271A25, K36344R30, K36444R30, K36745R30, K37179R30, K37568A30, K39247A30,
K39247B30, K39274A30, K39274B30, K39274C30, K39623B30, K39926A30,
K36344R60;
K36307R25, K36957R25, K37551A25, K41982A25, K42847A25, K38491A25,
K38758B25, K39629A25, K40123C25, K36307R30, K36957R30, K37295R30, K37551A30,
K38162A30, K38162B30, K41982B30, K38491B30, K38758A30, K38758C30, K38758D30,
K39629B30, K40123A30, K40123B30, K36307R60;
K40913R25, K41481R25, K42060R25,
K42572R25, K42959R25, K40913R30, K41481R30, K42060R30, K42061R30, K42572R30,
K42959R30;
K35731B25, K42045A25, K38703A25, K39420B30, K40491A25, K41042A25,
K35731A30, K35731E30, K35731F30, K35731G30, K38703B30, K39420A30, K40007A30,
K40007B30, K40491B30, K41042B30, K35731C60, K35731D90;
K41294R25, K37642R25,
K41723R30, K43115R30, K37642R30;
K37651R25, K37651R30;
K43134R25,
K43134R30;
K42848R25, K43348R25, K42848R30, K43348R30;
K38490A25,
K42776R25, K43141R25, K40097B25, K38490A30, K42776R30, K43141R30,
K40097A30;
K36253A25, K36723B25, K39505C25, K36253A30, K41609A30, K36723A30,
K39505A30, K36253A60;
K37766C25, K38442A30, K38442D25, K39290A25, K42147A25,
K42432A25, K40165A25, K40975B25, K37097A30, K37766A30, K37766B30, K38442B30,
K38442C30, K39290B30, K40487A30, K40487B30, K42147B30, K40165B30,
K40975A30;
K35855A25, K37805A25, K42143A25, K40406A25, K40974A25, K35667B30,
K35855C30, K35855D30, K36693A30, K37080A30, K38755A30, K42143B30, K39618A30,
K39739A30, K40406B30, K40406C30, K40974B30, K35667A60, K35855B60;
K35648A25,
K35656A25, K36377A25, K36713C25, K38545B25, K40379B25, K35758A30, K36377B30,
K36377C30, K36713A30, K36713B30, K36713D30, K37081A30, K37396A30, K38545A30,
K38545C30, K38693A30, K38693B30, K40379A30;
K39812A25, K40565A25, K39812A30,
K41575A30, K42117A30;
K39700A25, K43146A25, K39700A30,
K40566A30;
K42384A25, K39814A25, K39814A30, K40492A30,
K40492B30;
K34944C25, K35364A25, K38464A25, K41607A25, K40158A25, K38464B30,
K41607B30, K39696A30, K39696B30, K40158B30, K40489A30, K34944A60, K34944B60;
K41311R25, K41920R25, K42305R25, K42811R25, K41311R30, K41920R30, K42305R30,
K42811R30;
K40651R25, K41295R25, K41757R25, K42574R25, K42958R25, K43406R25,
K40651R30, K41295R30, K41757R30, K42574R30, K42958R30, K43406R30;
K40647R25,
K41099R25, K41891R25, K42202R25, K42802R25, K43350R25, K40647R30, K41099R30,
K41891R30, K41892R30, K42202R30, K42802R30, K43350R30;
K36663R30, K37343R30,
K37716A30, K37064R30, K41602A30, K38054A30, K38054B30, K38632A30, K38756A30,
K38756B30, K39438A30, K39438B30, K41050A30;
K42690R30, K41475R30, K42078R30,
K42309R30, K40910R30;
K36663R25;
K42778R25, K43082R25, K42778R30,
K43082R30;
K42936R25, K42936R30;
K42935R25, K42935R30;
K36219B25,
K37050A25, K38596B25, K40411A25, K36219A30, K37400A30, K37400B30, K37767A30,
K38596A30, K38596C30, K38596D30, K39462A30, K40919A25, K40919B30,
K41140A30;
K37768A25, K38492A25, K42289A25, K40412B25, K36410A30, K36410B30,
K37014A30, K37399A30, K37399B30, K38492B30, K38493A30, K39463A30, K40412A30,
K40972A30;
K38435A25, K42162A25, k39891A25, K40222B25, K36407A30, K36407B30,
K37051A30, K37821A30, K38702A30, K39289A30, K39891B30, K40222A30,
K41054A30;
K42496R30;
K36799A25, K41950A25, K42581A25, K39921A25,
K36799B30, K36800B30, K40298A30, K36348A60, K36800A60, K36800C60, K41950B60,
K39921B60, K39921C60, K39921D60;
K41421A25, K39524A25, K39923B25, K40490A25,
K41420B30, K41421B30, K39524B30, K3971930, K39923A30, K39923C30, K40324A30,
K40490B30, K40762A30, K40762B30;
K41600A25, K43195A25, K39002A25, K40761A25,
K40761C25, K41599A30, K41600B30, K38559A30, K38559B30, K39002B30, K40285A30,
K40285B30, K40761B30, K40761D30;
K41600A25, K43195A25, K39002A25, K40761A25,
K40761C25, K41599A30, K41600B30, K38559A30, K38559B30, K39002B30, K40285A30,
K40285B30, K40761B30, K40761D30;
K42137A25, K39079A25, K39079C25, K40888A25,
K37297A30, K37737A30, K38992A30, K39079B30, K39079D30, K39171A30, K40413A30,
K40413B30, K40888B30;
K42265A25;
K37283A25, K37745A25, K37745B25,
K38751A25, K39863A25, K39863B25, K41254B25, K37283A30, K37745C30, K38751B30,
K38751C30, K39332A30, K39863C30, K41254A30;
K37282A25, K38541A25, K38541B25,
K42417A25, K40189A25, K40189B25, K37282A30, K37689A30, K38541C30, K42417B30,
K38918A30, K38918B30, K39329A30, K40981A30;
K42527A30;
K36812A25,
K42239A25;
K41409R25, K41972R25, K42286R25, K42934R25, K41409R30, K41972R30,
K42286R30, K42934R30;
K42915A25, K36517A30, K37770B30, K38121A30, K38121B30,
K37770A60;
K36129A25, K36129B25, K36226B25, K36226C25, K36226E25, K36809C25,
K38082B25, K38883A25, K42564A25, K35538A30, K35852A30, K36226D30, K36809A30,
K36809B30, K38082A30, K38082C30, K38554A30, K42564B25, K39709A30, K39709B30,
K34172A60, K36226A60;
K43057R25, K43145R25, K43057R30,
K43145R30
RECALLING FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH,
REASON
Mispacked; possibility of a product package
mix-up.
VOLUME OF PRODUCT IN COMMERCE 440,148
units
DISTRIBUTION Nationwide
PRODUCT Docusate Sodium Softgels,
100 mg, packed in bulk cartons containing 18,000 softgel capsules for further
manufacturing, processing or repackaging. Banner™, Product code: LPE-68,
CODE
Lot number: 26040562
RECALLING
FIRM/MANUFACTURER Banner Pharmacaps, Inc., High Point, NC, REASON Presence of foreign capsule; Vitamin E, 400
I.U.
capsules mixed with the product.
VOLUME OF PRODUCT IN
COMMERCE 4,502,500 capsules
DISTRIBUTION MI
PRODUCT Product Description:
Stool Softener, (docusate sodium) Stool Softener Laxative Softgels, 100 mg each,
packaged in bottles of 60 and 100, ALSO packaged under the following brand
names: HyVee, NDC 42507-486-72; Target, NDC 11673-486-78; TopCare, NDC
36800-486-78 and 36800-486-72,
CODE Lots 6GE0038
and 6GE0068; exp. 03/2008.
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Perrigo Company, Allegan, MI,
Manufacturer: Banner Pharmacaps Inc, High Point NC.
REASON
Presence of foreign capsules; Vitamin E,
400 I.U. capsules mixed with the product.
VOLUME OF PRODUCT IN
COMMERCE 41,544 bottles
DISTRIBUTION Nationwide
500mg Strength Store-Brand Acetaminophen Caplets Contain Metal Fragments
Perrigo Company (Perrigo) of Allegan, Michigan is recalling 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
Consumers should consult their physician if they suspect they've been harmed by use of this product.
Consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department, 877-546-0454 for further instructions. Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number.
Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.
WEEK
ENDING NOVEMBER 18
PRODUCT Amantadine Hydrochloride
Capsules, USP, 100mg, packaged in 100 and 500 count bottles,
CODE
Batch #215103, Expiration 10/07 (bottles of 500).
Batch #215105, Expiration 10/07 (bottles of 500). Batch #223755, Expiration
03/07 (bottles of 100).
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Upsher Smith Laboratories, Inc., Maple Grove, MN,
Manufacturer: Banner
Pharmacaps, Inc., High Point, NC.
REASON Failed USP Test Requirements
for Content Uniformity.
VOLUME OF PRODUCT IN COMMERCE 1,497
bottles/#215103; 956 bottles/#215105; 6,097
bottles/#223755
DISTRIBUTION Nationwide
PRODUCT Derma 50 Wound Care
Ointment, Emu Oil, 2 oz. jar,
CODE Lot:
3/16/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purple
Emu/PEL Naturals, Woxall, PA,
Manufacturer: Iren Corp., Union Dale, PA.
REASON
Undeclared Sulfur
VOLUME
OF PRODUCT IN COMMERCE 255 bottles
DISTRIBUTION Nationwide,
UK, Canada, and England
PRODUCT Precedex® (Dexmedetomidine Hydrochloride) Injection, Equivalent to 100
mcg/mL
Dexmedetomidine base, 2 mL single-dose vial, Rx only, NDC 0409-1638-02, CODE
Lots: 37-483-DK and 38-481-DK
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc, Lake Forest, IL,
Manufacturer:
Hospira, Inc, Rocky Mount,
NC.
REASON Degradation
impurities may exceed specification over shelf life.
VOLUME OF PRODUCT IN
COMMERCE 142,925 units
DISTRIBUTION Nationwide and Dominica
Republic
PRODUCT Metoclopramide USP
Tablet, 5mg, NDC 61392-557-30, NDC 61392-557-30 The medication is distributed in
30 count boxes containing single tablet unit dose strips,
CODE Lot Code: C41955A30, Expiration Date:
03/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Heartland Repack Services LLC, Toledo, OH,
Manufacturer: Pliva, Inc., East Hanover, NJ.
REASON
Broken Tablets
VOLUME OF PRODUCT
IN COMMERCE8,669/30 count boxes
DISTRIBUTION Nationwide
PRODUCT Akineton® (biperiden
hydrochloride) tablets, 2 mg, 100 tablet bottles, Rx only, NDC 49884-693-01,
CODE
Lot: 04AKT21001, exp. 03/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott
Park, IL,
Manufacturer: Abbott
Laboratories, Whippany, NJ.
REASON Product does not meet potency specifications
throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE 9,020/100
tablet bottles
DISTRIBUTION Nationwide and PR
PRODUCT Fougera® CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM USP 1%/0.05% (base), 15 gram and 45 gram tubes,
Rx only, NDC 0168-0258-15 (15 grams) and NDC 0168-0258-46 (46 grams),
CODE
15 gram lot: T244 (exp. date 8/07); 45 gram lots:
S969 (exp. date 6/07) and U268 (exp. date 1/08).
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY,
Manufacturer:
Altana, Inc.,
Hicksville, NY.
REASON Subpotent (betamethasone dipropionate)
VOLUME OF PRODUCT IN
COMMERCE 125,836/15 gram tubes; 85,254/45 gram
tubes
DISTRIBUTION Nationwide, PR, and Guam
Rockline Announces Product Withdrawal of Wet Wipes Products
Rockline Industries announced that it has initiated a nationwide product withdrawal to the retail level of certain lots of its store brand wet wipes. The withdrawal is a result of routine product testing that detected the presence of a micro-organism known as Burkholderia cepacia (B. cepacia).
Those products that are affected will likely have a bad odor described as sour milk.
The company encourages consumers who have purchased wet wipes between Aug. 21 and Nov. 17, 2006 to check the lot code of the product. The lot code, which is not the same as a bar code, is typically found on the back label or side panel of the package and includes the word "Lot" followed by a series of numbers. Affected products have lot codes with the first 5 digits beginning at 06233 and ending at 06253. These numbers will be followed by either 0220197 or 0220693. No other lot codes or products are affected. Perlman recommended discontinuing use of the product and returning the package to the place of purchase for a full refund or replacement.
Affected products were packed in multiple brands including the following items sold at Wal-Mart stores and Sam’s Club:
|
Product Description |
Product Lot Code |
|---|---|
|
EQUATE Pop-Ups, Fragrance Free Baby Wipes, 80 Count Tub, |
LOT 06239 0220197XXXX |
|
EQUATE Pop-Ups, Fragrance Free Baby Wipes, 80 Count Refill, |
LOT 06250 0220197XXXX |
|
EQUATE Pop-Ups, Fragrance Free Baby Wipes, 160 Count Bag, |
LOT 06233 0220693XXXX |
|
MEMBER'S MARK Moist Wipes Pop-Ups, Fragrance Free, 720 Count Box,
|
LOT 06237 0220197XXXX |
For more information, contact Rockline Industries at 866-964-3322.
WEEK ENDING NOVEMBER 25
Advanced Medical Optics Announces Recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products
Advanced Medical Optics, Inc., a global ophthalmic surgical and eye care products company, today announced a nationwide, recall of certain lots of its 12-ounce COMPLETE® MoisturePLUS(TM) multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.
Lot numbers are located on the top of the product box and on the side of the product bottle. The recalled product lots include:
|
Package Lot No. |
Product Description |
Bottled Lot Number(s) in Kit |
|---|---|---|
|
ZB03087 |
COMPLETE MoisturePLUS Active Pack |
ZB03085, ZB02845 |
|
ZB03724 |
COMPLETE MoisturePLUS Active Pack |
ZB03713, ZB03506 |
|
ZB03734 |
COMPLETE MoisturePLUS Active Pack |
ZB03713, ZB03506 |
|
ZB03735 |
COMPLETE MoisturePLUS Active Pack |
ZB03713, ZB03510 |
|
ZB03736 |
COMPLETE MoisturePLUS Active Pack |
ZB03713, ZB03510 |
|
ZB03739 |
COMPLETE MoisturePLUS Active Pack |
ZB03737, ZB03510 |
|
ZB02710 |
COMPLETE MoisturePLUS 12oz (360 mL) |
ZB02709 |
|
ZB02714 |
COMPLETE MoisturePLUS 12oz (360 mL) |
ZB02713 |
|
ZB02718 |
COMPLETE MoisturePLUS 12oz (360 mL) |
ZB02717 |
|
ZB02722 |
COMPLETE MoisturePLUS 12oz (360 mL) |
ZB02721 |
|
ZB02746 |
COMPLTE MoisturePLUS 2 X 12 oz |
ZB02745 |
|
ZB02750 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02749 |
|
ZB02771 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02770 |
|
ZB02792 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02791 |
|
ZB02796 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02795 |
|
ZB02800 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02799 |
|
ZB02804 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB02803 |
|
ZB03535 |
COMPLETE MoisturePLUS 2 X 12 oz |
ZB03534 |
Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-877-884-7779 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time or visit http://www.amo-inc.com/ for instructions. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-877-884-7779 Monday through Friday from 8 a.m. through 5 p.m. Eastern Time for more information.
Product from the recalled lots was distributed nationwide to food, drug and mass merchandiser accounts. The recall does not include 4-ounce and 16-ounce bottles, or professional samples and packs provided to eye care practitioners.
PRODUCT Paxil CR (Paroxetine HCl)
controlled-release tablets, 37.5 mg, 30 tablet bottles, Rx only, NDC
0029-3208-13,
CODE Lots: 303-6P08, exp 3/08;
304-6P08, exp. 3/08; 305-6P08, exp. 3/08
RECALLING
FIRM/MANUFACTURER Sb Pharmco Puerto Rico Inc., Cidra, PR, REASON Due
to an intermittent manufacturing equipment malfunction some tablets may not
contain active ingredient.
VOLUME OF PRODUCT IN COMMERCE 211,677/30
tablet bottles
DISTRIBUTION Nationwide, Hawaii, and PR
PRODUCT Prednisolone Sodium
Phosphate Oral Solution, 5 mg/5 mL, 4 fl oz bottles, Rx only, NDC 60432-089-04,
CODE
Lot 27583A, exp. 2/07
RECALLING
FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, IL,
REASON One individual unknown impurity level exceeds
specification.
VOLUME OF PRODUCT IN COMMERCE 528/4 fl. oz.
bottles
DISTRIBUTION Nationwide