APRIL 2002
WEEK
ENDING APRIL 6
PRODUCT Oxygen USP, compressed in size C, D and E in steel
and aluminum Cylinders.
CODE Lots 020501/4, 020502/5, 020503/4 and 020504/5.
RECALLING FIRM/MANUFACTURER Southern Welding Supply Co.,
Inc., Savannah, GA
REASON Good Manufacturing Practice (GMP's) deviations
including, but not limited to, failure to test product for purity and identity.
VOLUME OF PRODUCT IN COMMERCE 70 cylinders.
DISTRIBUTION GA.
PRODUCT Necon 1/50-28 Tablets (Norethindrone 1.0 mg and
Mestranol 0.05 mg. Cartons of six (6) tablet dispensers, twenty eight (28)
tablets each. Each light blue tablet (21) contains noethindrone 1 mg and
mestranol 50 mcg. Each white tablet
contains inert ingredients.
CODE
Lot
& Exp. Amnt Dist.
No. Cust.
(ctns)
51001X99
12/2002 6936 78
51001B00
3/2003 6501 88
51001D00
4/2003 7176 85
51002D00
4/2003 7231 58
RECALLING FIRM/MANUFACTURER Watson Pharmaceuticals,
Inc., Corona, CA
REASON Subpotent for mestranol component (stability).
VOLUME OF PRODUCT IN COMMERCE 27,844.
DISTRIBUTION Nationwide and Puerto Rico.
WEEK ENDING APRIL 13
PRODUCT Sulfur Sublimed Powder, USP, 4 oz plastic bottle,
Humco Trademark. Sodium Bicarbonate Oral Powder, USP, 4 oz bottle, Humco
Trademark.
CODE
Sulfur
Sublimed Sodium Bicarbonate
Powder USP Oral
Powder USP
Lot
No 237059 272629
Humco
Catalog No. 279994001
268594001
AmeriSource
Cat No. Unknown
1973832
Borschow
Cat. No. not in catalog
H7567
Exp.
Date 10/05 6/05.
RECALLING FIRM/MANUFACTURER Borschow Hospital &
Medical Supplies, Inc., Hato Rey, Puerto Rico
REASON Mislabeling of Sulfur Sublimed as Sodium Bicarbonate
by product price label supplied by Borschow Hospital & Medical Supplies.
VOLUME OF PRODUCT IN COMMERCE 152 units.
DISTRIBUTION Puerto Rico.
PRODUCT Pentothal, Ready to Mix Syringe, Thiopental Sodium
for Injection, 500 mg. 2.5% (25 mg/mL) vial, 20 ml Abboject Syringe, and
Sterile Water in a 20 mL Fliptop Vial and Injector, 25 kits per case.
CODE Lot No. 80-076-DK.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott
Laboratories, Abbott Park, IL
Manufacturer:
Abbott Laboratories, Rocky Mount, NC.
REASON Component Mix-up.
VOLUME OF PRODUCT IN COMMERCE 18,000 units.
DISTRIBUTION Nationwide.
PRODUCT a) Chloral Hydrate Syrup USP, 500 mg/5mL, 5 mL unit
dose cups, 10 cups per tray, 10 trays per case.
b)
Phenobarbital Elixir, 20 mg/5 mL, 5 mL unit dose cups, 10 cups per tray, 10
trays per case.
CODE a) Lots 1E46, 1H52, 1K17; b) Lot 1K49
RECALLING FIRM/MANUFACTURER Pharmaceutical Associates,
Inc., Greenville, SC
REASON Overfill of drug cups which could lead to twice the
labeled amount of active ingredient being dispensed.
VOLUME OF PRODUCT IN COMMERCE a) 284,860/5 mL cups; b)
4,207/5 mL cups.
DISTRIBUTION Nationwide.
PRODUCT Meclizine Tablets 25 mg, 30 tablets per bottle,
labeled as Packaged by QCP. Rx Only.
CODE Lot 00037, Exp. 6/30/03
RECALLING FIRM/MANUFACTURER Recalling Firm: Quality Care
Products, L.L.C. Temperance, MI
Manufacturer: Par Pharmaceutical, Spring Valley, NY.
REASON Mispackaging at repacking firm; bottles labeled as
25 mg actually contain 12.5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE 33 bott les.
DISTRIBUTION OK, TN, and WI.
PRODUCT Epinephrine Mist Kit, Epinephrine Inhalation Aerosol,
USP, 5.5 mg/mL 1/2 Fl. Oz., Kit contains nebulizer/actuator
packaged
with vial.
Epinephrine
Mist-Epinephrine Inhalation Aerosol USP Refill, 5.5 mg/mL, packaged in 0.5
ounce plastic coated glass vials, 1 vial per box,
24
boxes/carton.
CODE Kit with Inhaler (1/2 oz)
Lot
Number Expiration Date
RB0166 28-Feb-02
RB0170 28-Feb-02
RB0171 31-Mar-02
RB1200 31-Jan-03
RB1201 31-Jan-03
RB1204 28-Feb-03
RB1205 28-Feb-03
RB1207 28-Feb-03
RB1208 28-Feb-03
RC0176 30-Apr-02
RC1209 28-Feb-03
RC1213 31-Mar-03
RD0178 30-APR-02
RD0180 31-Mar-02
RD0182 30-Mar-02
RD0183 30-Mar-02
RF1414 30-Mar-03
RH0543 30-Jun-02
RH0544 31-Jul-02
RH0547 31-Jul-02
RH0548 31-Jul-02
RJ1669 30-Jun-03
RJ1671 30-Jun-03
RJ1672 30-Jun-03
RK0551 31-Aug-02
RK0552 31-Aug-02
RK0553 31-Aug-02
RK0689 30-Sep-02
RK1676 31-Jul-03
RK1677 31-Jul-03
RK1680 31-Aug-03
RL0690 30-Sep-02
RL0691 30-Sep-02
RN0698 31-Oct-02
RN0699 31-Oct-02
RN0700 31-Oct-02
RP0834 31-Oct-02
RP0835 31-Oct-02
RS0840 31-Jan-03
RS0841 31-Jan-03
Refill
(1/2 oz)
Lot
Number Expiration Date
RB0167 28-Feb-02
RB0168 28-Feb-02
RB0169 28-Feb-02
RB1202 28-Feb-03
RB1203 28-Feb-03
RB1206 28-Feb-03
RC0172 31-Mar-02
RC0173 03-Jan-00
RC0177 28-Feb-02
RC1210 31-Mar-03
RC1211 31-Mar-03
RC1212 31-Mar-03
RC1214 31-Mar-03
RD0179 31-Mar-02
RD0181 30-Mar-02
RD0410 31-Mar-03
RD1405 30-APR-03
RD1406 31-May-03
RD1407 31-May-03
RD1408 31-May-03
RD1409 31-May-03
RF1410 31-Mar-03
RF1412 31-Mar-03
RF1413 31-Mar-03
RH0542 30-Mar-02
RH0545 31-Jul-02
RH0546 31-Jul-02
RH0549 31-Aug-02
RH0550 31-Aug-02
RJ1670 30-Jun-03
RJ1674 30-Jun-03
RK0554 31-Aug-02
RK0555 31-Aug-02
RK0688 31-Aug-02
RK1675 31-Jul-03
RK1678 31-Jul-03
RK1679 31-Aug-03
RL0692 30-Sep-02
RL0693 30-Sep-02
RL0694 30-Sep-02
RL0695 31-Oct-02
RL1977 31-Aug-03
RN0696 31-Oct-02
RN0701 31-Oct-02
RP0833 31-Oct-02
RP0836 30-Nov-03
RP0837 30-Nov-03
RP0838 31-Jan-03
RS0839 31-Jan-03
RS0841 31-Jan-03
RS0841 31-Jan-03
RS0842 31-Jan-03
RS0843 31-Jan-03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpharma USPD, Baltimore, MD
Manufacturer: Armstrong Laboratories, Inc., West Roxbury,
MA.
REASON Failure to test Purified Water ingredient for all
microbial specifications.
VOLUME OF PRODUCT IN COMMERCE 4,333,356 units.
DISTRIBUTION Nationwide.
PRODUCT Aspirin and Codeine Phosphate Tablets, 325mg/30mg,
100 tablet bottles, Rx only. The product is sold under the Vintage, Qualitest,
and URL labels.
CODE Lot Numbers 129089A, 129089B, 129089C, 129089D,
108080A, 108080B, 108080C, 108080E, 108080F, 108080G, 011120A, 011120B,
011120C, 011120E.
RECALLING FIRM/MANUFACTURER Recalling Firm: Vintage
Pharmaceuticals, Huntsville, AL
Manufacturer: Vintage Pharmaceuticals, Charlotte, NC.
REASON Codeine Phosphate component may not maintain potency
throughout labeled expiry date.
VOLUME OF PRODUCT IN COMMERCE 58,368 units.
DISTRIBUTION AL.
PRODUCT Clartin-D 12 Hour Tablets, (5 mg Loratadine/120 mg pseudoephedrine
sulfate, USP), Extended release tablets, Rx only, 100 tablet bottles, 100 unit
dose tablets, and 30 tablet blister packs.
CODE All lots with the prefix number of "0" or
"1" (representing the years 2000 and 2001 respectively). Also lots 9-JRP-
313,
9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042.
Batch Exp. Date Batch Exp. Date Batch Exp. Date
0-JRP-134 04/2003 0-JRP-256 10/2003
1-JRP-2045 05/2004
0-JRP-153 04/2003 1-JRP-10 12/2003
1-JRP-2047 04/2004
0-JRP-2000
07/2002 1-JRP-113 02/2004
1-JRP-2049 05/2004
0-JRP-2001
10/2002 1-JRP-2000
06/2003 1-JRP-2052 03/2004
0-JRP-2003
08/2002 1-JRP-2004
06/2003 1-JRP-2053 03/2004
0-JRP-2005
10/2002 1-JRP-2005
10/2003 1-JRP-2055 05/2004
0-JRP-2006
01/2003 1-JRP-2007
08/2003 1-JRP-2057 03/2004
0-JRP-2008
12/2002 1-JRP-2009
10/2003 1-JRP-2058 05/2004
0-JRP-2009
01/2003 1-JRP-2011
10/2003 1-JRP-2060 03/2004
0-JRP-2010
02/2003 1-JRP-2012
05/2003 1-JRP-2061 05/2004
0-JRP-2011
02/2003 1-JRP-2013
10/2003 1-JRP-2062 05/2004
0-JRP-2013
02/2003 1-JRP-2014
12/2003 1-JRP-2063 05/2004
0-JRP-2016
02/2003 1-JRP-2015
10/2003 1-JRP-2064 05/2004
0-JRP-2017
02/2003 1-JRP-2016
01/2003 1-JRP-2065 05/2004
0-JRP-2022
03/2003 1-JRP-2019
12/2003 1-JRP-2066 05/2004
0-JRP-2023
02/2003 1-JRP-2020
01/2004 1-JRP-2067 05/2004
0-JRP-2025
03/2003 1-JRP-2021
08/2003 1-JRP-2068 05/2004
0-JRP-2027
04/2003 1-JRP-2022
01/2004 1-JRP-292 01/2003
0-JRP-2028
04/2003 1-JRP-2023
01/2004 1-JRP-324 01/2003
0-JRP-2029
03/2003 1-JRP-2024
01/2004 1-JRP-46 01/2004
0-JRP-2031
04/2003 1-JRP-2025
01/2004 1-JRP-52 01/2004
0-JRP-2033
04/2003 1-JRP-2026
01/2004 9-JRP-2040 09/2002
0-JRP-2034
04/2003 1-JRP-2027
01/2004 9-JRP-2041 10/2002
0-JRP-2036
05/2005 1-JRP-2028
08/2003 9-JRP-2042 10/2002
0-JRP-2039
02/2003 1-JRP-2029
02/2004 9-JRP-313 11/2002
0-JRP-2047
03/2003 1-JRP-203 09/2002
9-JRP-338 11/2002
0-JRP-2048
03/2003 1-JRP-2030 01/2004
0-JRP-2049
05/2003 1-JRP-2031 01/2004
0-JRP-2050
05/2003 1-JRP-2032 02/2004
0-JRP-2051
05/2003 1-JRP-2033 02/2004
0-JRP-2052
05/2003 1-JRP-2035 02/2004
0-JRP-2053
06/2003 1-JRP-2036 03/2004
0-JRP-2054
07/2003 1-JRP-2037 03/2004
0-JRP-2055
07/2003 1-JRP-2040 03/2004
0-JRP-2056
05/2003 1-JRP-2044 04/2004.
RECALLING FIRM/MANUFACTURER Schering Corp., Kenilworth,
NJ
REASON Dissolution failure; pseudoephedrine sulfate
component (5th hour/18 month stability).
VOLUME OF PRODUCT IN COMMERCE 7,875,653 units.
DISTRIBUTION TX, PA, CA, DE and VA.
PRODUCT Claritin-D 12 Hour Extended Release Tablets, (5 mg
loratadine/120 mg pseudoephedrine sulfate, USP); Rx Only,
Packaged
in a) 20 tablet bottle (Product No.
4094-0); b) 14 tablet bottle (Product No. 4094-1); c) 60 tablet bottle (Product
No. 4094-2);
d)
10 tablet bottle (Product No. 4094-3).
CODE a) 0042080, 0055010, 0101117, 0146013, 0160042,
0174010, 0195010, 0244057, 0269160, 0291101, 0318124, 0334073, 0349135,
0363122, 1025185, 1046228, 1067144, 1086185, 1102132, 1122197, 1142124,
1157100, 1193162, 1220148, 1234121, 1254105, 1262128, 1281162, 1317148,
1325191, 1330163, 1354100, 2015153, 2023112;
b)
0039104, 0063047, 0117108, 0154036, 0189024, 0208100, 0264132, 0290115,
0320132, 0332205, 0335205, 0341185, 1360424, 1362043, 2011112, 2018088
c)
0084051, 0098022, 0111068, 0157159, 0166112, 0231024, 0249120, 0259030,
0278118, 0307047, 0343028, 1003155, 1019179, 1032136, 1068023, 1078146,
1099136, 1123198, 1129153, 1141136, 1151198, 1170147, 1229041, 1247163,
1269187, 1276189, 1290107, 1306025, 1338183, 1348039,
2009151,
2042179
d)
0049098, 0053185, 0234125, 0238040, 0341212, 0354178, 1109179, 1115217,
1117053, 1124051, 1124120, 1129103, 1131049.
RECALLING FIRM/MANUFACTURER Allscripts Healthcare
Solutions, Libertyville, IL
REASON Dissolution failure (at manufacturer, Schering
Corp); pseudoephedrine sulfate component (5th hour/18 month stability).
VOLUME OF PRODUCT IN COMMERCE 84,392 tablets.
DISTRIBUTION Nationwide.
WEEK ENDING APRIL 20
PRODUCT a) Levothyroxine Sodium, USP, tablets, 25 mcg (0.025
mg) Rx Only 100 and 1,000 count
bottles.
b)
Levothyroxine Sodium, USP, tablets, 50 mcg (0.05 mg) Rx Only 100 and 1,000 count bottles2.
Both
strengths are sold under the Vintage, Qualitest and URL brand labels.
CODE a) Levothyroxine Sodium 0.025 mg 042040A, 042040B, 042040C, 042040D, 042040E,
020030A, 020030B, 041040A, 041040B, 041040C;
b)
Levothyroxine Sodium 0.05 mg 004129C,
004129D, 004129E.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals,
Inc., Charlotte, NC
REASON Stability; Inability to maintain potency throughout
the labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE a) 15,795 bottles 0.025 mg
size; b) 13,043 bottles 0.05 mg size.
DISTRIBUTION AL.
PRODUCT Calcijex, Calcitriol Injection, For I.V. use,1
mcg/mL single dose ampul, Rx Only.
CODE Lot No. 85-305-DK, Exp Date May 1, 2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Abbott Park, IL
Manufacturer: Abott Laboratories, Rocky Mount, NC.
REASON Mispackaging:
Vitamin K1 Injection found in a box of Calcijex injection.
VOLUME OF PRODUCT IN COMMERCE 126,075 units.
DISTRIBUTION Nationwide.
PRODUCT Paclitaxel Injection, 6 mg/ml, packaged in 5 ml,
16.7ml, and 50 ml Multiple-Dose vials, Rx only.
CODE Lot Numbers/Expiration Dates: #271220, Exp. June
2003; #236135, Exp. June 2003; #236137,
Exp. July 2003; #323242, Exp. Aug 2003;
#271224,
Exp. Aug 2003; #271225, Exp. Aug 2003;
#271226, Exp. Aug 2003; #271227, Exp.
Sept 2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH
REASON Impurity levels are exceeding specifications (during
stability testing).
VOLUME OF PRODUCT IN COMMERCE 33,216 vials.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT HAND MEDIC Antiseptic Skin Treatment, OTC, packaged
in 500 ml cartridges, and 2 oz, 4 oz, and 8 oz bottles. Active ingredient:
Benzalkonium
Chloride 0.1%.
The
500 ml cartridges are sealed poly bags inside a rectangular cardboard box, 6
per case.
All
bottles are black plastic, 12 per case (2 oz & 4 oz bottles), or 6 per case
(8 oz bottles).
The
500 ml cartridges, and the 4 oz and 8 oz bottles are packaged under the GOJO
brand label; and the 2 oz bottles are
packaged
under
either the GOJO brand or Pro-Link brand labels.
The
product catalog numbers are as follows:#8242-06 (500 ml cartridges); #8142-12
(2 oz); #8147-12 (4 oz).#8145-06 (8 oz)
CODE Lot Numbers: 165461, 166095, 166581, 166826, 167503,
168453, and 168912.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc.,
Cuyahoga Falls, OH
REASON Superpotency of the active ingredient (Benzalkonium
Chloride).
VOLUME OF PRODUCT IN COMMERCE 9,703 cases.
DISTRIBUTION Nationwide.
PRODUCT PROVON Medicated Lotion Soap with Triclosan, OTC,
packaged in 12 fl. oz. white plastic bottles.
Active ingredient: Triclosan 0.3%, Product Number 4153-12. The bottles are packaged under the GOJO
brand label. A case contains 12-12 fl oz bottles with a pump closure in
cardboard box.
CODE Lots #169738 and #168862.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc.,
Cuyahoga Falls, OH
REASON Misbranding: Back bottle label declares incorrect
active ingredient.
VOLUME OF PRODUCT IN COMMERCE 37 cases.
DISTRIBUTION WI, IL, WA, MO, NE, LA, MA, and CA.