AUGUST 2005
WEEK
ENDING AUGUST 6
PRODUCT Maxipime (cefepime
hydrochloride, USP) for Injection, Equivalent to 1 gram, 15mL Single-Dose Vial,
box of 10 vials, For IV or IM Use after constitution, Rx only, NDC 51479-054-30
CODE
Lots: 5E02293, exp 4/30/2008; 5E01410, exp
4/30/2008; 5E00604, exp 4/30/2008; 5E01868, exp 3/31/2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bristol Meyers Squibb Company,
New Brunswick, NJ,
Manufacturer: Bristol-Myers Squibb S.r.l.,
Sermoneta-Latina,
Italy.
REASON Mislabeled;
incorrect bar code on 10-pack tray. Bar code indicates 2 gram vials instead of 1
gram vials.
VOLUME OF PRODUCT IN
COMMERCE 266,940
DISTRIBUTION Nationwide
PRODUCT Hyoscyamine Sulfate Oral
Solution, USP, Hyoscyamine Sulfate, USP 0.125mg, Alcohol 5%, 15mL bottle, Rx
only, NDC 0603-1314-73
CODE Lot L030L04A, Exp
11/06
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC,
Huntsville, AL
REASON Impurity; extraneous peak was discovered during
routine long-term stability testing.
VOLUME OF PRODUCT IN
COMMERCE 11,611 units
DISTRIBUTION Nationwide and PR
PRODUCT
a) Stannous Flouride
0.63% Concentrate Oral Rinse, 10 oz (283 g) bottle, Mint Flavor, Rx only,
39110,
NDC 60258-159-10
b) Andehist -NR Syrup, Each
teaspoonful (5mL) contains: 4mg and Pseudoephedrine Hydrochloride 45mg, 16
fl oz (473 mL) bottle, Rx only, NDC 60258-434-16,
c) Andehist-NR Oral Drops, Each dropperful (1mL)
contains: Carbinoxamine
Maleate 1mg and Pseudoephedrine Hydrochloride 15mg, 1 fl oz (30mL)
bottle, Rx only, NDC 60258-435-30,
d) Andehist-DM NR
Syrup, Each teaspoonful (5mL) contains: Brompheniramine Maleate 4mg,
Pseudoephedrine Hydrochloride 45mg and Dextromethorphan Hydrobromide
15mg, 16 fl oz
(473 mL) bottle, Rx only, NDC 60258-444-16,
e) Bromhist-DM Drops, Each dropperful (1mL)
contains:
Brompheniramine Maleate 1mg,
Pseudoephedrine Hydrochloride 15mg and Dextromethorphan Hydrobromide 4mg, 1 fl oz
(30mL) bottle, Rx only, NDC
60258-447-30,
f) Dytan Suspension, Each 5mL (one
teaspoonful) contains: Diphenhydramine Tannate 25mg, 4 fl oz (120mL)
bottle, Rx only, NDC 63717-570-04,
g) Dytan-D
Suspension, Each 5 mL (one teaspoonful) contains: Diphenhydramine Tannate
25mg and
Phenylephrine Tannate 7.5 mg, 4 fl oz (118mL), Rx only. NDC
63717-576-04
CODE
a) Lot Nos.: L402003,
402004;
b) Lot Nos.: 3K06, L401002, 3L06, 3L05;
c) Lot Nos.: 3L07,
3L08;
d) Lot Nos.: 3L02, 3L03, L401001;
e) Lot No.: 3L06;
f) Lot Nos.:
L409001A, L409002A;
g) Lot Nos.: L401007, L401008, L401009, L401010, L4034002, L404002, L404003, L404004, L404005
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cypress Pharmaceutical, Inc,
Madison, MS
Manufacturer: Able Laboratories,
Inc., Cranbury, NJ.
REASON Lack
of assurance that testing conducted for release and stability conformed to
standard operating procedures (Able Labs)
VOLUME OF PRODUCT IN
COMMERCE 156,197 units
DISTRIBUTION Nationwide
PRODUCT
CVS pharmacy brand Wart
Remover, Maximum Strength, Salicylic Acid, 17% w/w, Net Wt. ½ oz (14mL); Over
the Counter, UPC # 0 50428 21032
CODE Lot Nos.
5A012A (exp. 01/07) and 5E001 (exp. 02/07)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Clay Park Labs, Inc., Bronx, NY
Manufacturer:
Pharma Pac LLC, De Kalb, MS.
REASON Mislabeled: cartons of CVS pharmacy brand Wart
Remover (Liquid) were printed with the Drug Facts Panel referencing Corn Remover
(Liquid).
VOLUME OF PRODUCT IN COMMERCE 45,642
units
DISTRIBUTION Nationwide
PRODUCT Renaphro Softgels, Each
softgel contains: Vitamin C 100mg, Folic Acid 1mg, Niacinamide 20mg, Thiamine
Mononitrate 1.5mg, Riboflavin 1.7mg, Vitamin B6 10mg, Vitamin B12 6mcg, Calcium
Pantothenate 5mg and Biotin 150 mcg, 100 count bottles, Stress/Dialysis Vitamin,
Rx only, NDC 64980-114-01
CODE All lots whose
first 3-digits start with ì664î.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Rising Pharmaceuticals, Inc.,
Allendale, NJ
Manufacturer: Strides Inc.,
Somerset, NJ.
REASON Subpotent;
calcium pantothenate
VOLUME OF PRODUCT IN COMMERCE 208,692 Units
(100's) were distributed
DISTRIBUTION Nationwide and PR
WEEK ENDING AUGUST 13
PRODUCT K Effervescent Tablets
Potassium (978mg), Orange Flavored, Potassium Bicarbonate Effervescent Tablets
for Oral Solution, Rx only, 30 Effervescent Tablets, NDC 0603-4170-16,
CODE
KL40834-1, Exp. 8/07, and KL50126-1, Exp.
1/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bajamar Chemical
Co, Inc., Olivette, MO
Manufacturer: Project Inc., St. Louis, MO.
REASON
Mispacked; outer carton incorrectly labeled as K
Effervescent Tablets actually contains correct labeled product Effervescent
Potassium/Chloride Tablets Fruit Punch Flavor.
VOLUME OF PRODUCT IN
COMMERCE 7,680/30-tablet boxes
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 20
PRODUCT Adrenalin Chloride
Solution, (Epinephrine Nasal Solution, USP), 1mg per mL, 1 fl oz (30 mL) bottle
Vasoconstrictor, For Topical Application 1:1000, Rx only, NDC 61570-300-31
CODE
Lot No. 005D4M, exp. 06/06
RECALLING
FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc.,
Bristol, TN
Manufacturer: Parkdale
Pharmaceuticals, Inc., Rochester, MI.
REASON Defective container, split cap thread defects which
may lead to a lack of sterility assurance.
VOLUME OF PRODUCT IN
COMMERCE 16,887 units
DISTRIBUTION Nationwide
PRODUCT
a) Phenazopyridine HCL
Tablets, 100 mg, bottles of 8, 10, 12, and 15, Rx, NDC 49999-047-xx,
b) Phenazopyridine HCL Tablets, 200 mg, bottles of 6, 9, 10, and 15, Rx, NDC 49999-176-xx,
c)
Propoxacet-N Tablets, (propoxyphene napsylate, USP 100 mg and Acetaminophen
650 mg), in bottles
of 6, 10, 12, 15, 20, 30, 50, 60, 90, and 100, Rx,
NDC 49999-025-xx,
d) Naproxen Sodium Tablets, 550 mg., in
bottles of 20, 28, 30, and 60. Rx, NDC 49999-0058-xx.
e) Metronidazole Tablets, 500 mg, in bottles of 14,
21, 28 and
100, Rx, NDC 49999-095-xx,
f) Indomethacin Capsules, 25
mg, in bottles of 15, 20, 30 and 90, Rx, NDC 49999-234-xx,
g) Indomethacin Capsules, 75 mg, Extended-Release,
in bottles of
30, Rx, NDC 49999-0371-xx,
h) APAP 300 mg/Codeine 30 mg
Tablets (acetaminophen and codeine phosphate), in bottles of 10, 12,
15,
20, 30, 50, 60 and 100, Rx, NDC 49999-060-xx,
CODE All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical &
Surgical, Temperance, MI
Manufacturer:
Able Laboratories Inc., S Plainfield, NJ.
REASON Lack of assurance that testing conducted for release and
stability conformed to standard operating procedures (Able Labs).
VOLUME
OF PRODUCT IN COMMERCE 3,325
bottles
DISTRIBUTION Nationwide
PRODUCT Antacid Tablets Ultra
Strength (calcium carbonate) 500mg, 72 Chewable Tablets, Assorted Fruit, CVS
pharmacy brand
CODE Lot 1717487 Exp. Dec
06
RECALLING FIRM/MANUFACTURER Guardian Drug Co., Inc, Dayton, NJ
REASON
Mislabeled; Back panel label incorrectly states the
strength of the product as Calcium carbonate 500 mg instead of actual strength
of Calcium carbonate 1000 mg.
VOLUME OF PRODUCT IN COMMERCE 6,527
bottles
DISTRIBUTION Nationwide
PRODUCT Creomulsion For Children
(dextromethorphan HBc, USP) 5 mg, 4 fl. oz. (118mL) bottles, Soothing Cough
Syrup, Cough Suppressant, Great Cherry Taste, Over-The-Counter, NDC
12099-0015-1, CODE Lot #G01
RECALLING
FIRM/MANUFACTURER Summit Industries, Marietta, GA
REASON Tamper Evident Seals
partially or completely broken.
VOLUME OF PRODUCT IN COMMERCE 808
cases -- approximately 9,696 bottles
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 27
PRODUCT
a) Econopred plus (prednisolone acetate) Sterile Ophthalmic
Suspension, 1%, 5 ml tradesize, 5
ml sample, 10 ml tradesize, and 10ml sample, Rx only, NDC 0098-0637-04, Also under other label as Prednisolone Acetate Ophthalmic
Suspension1%
b) Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Each mL contains Neomycin
Sulfate equivalent to
Neomycin 3.5mg, Polymyxin B Sulfate 10,000 units, Dexamethasone 0.1%,
Sterile, 5 ml tradesize, Rx only, Also sold in Saudia Arabia as Maxitrol
Sterile Ophthalmic Suspension,
c) TobraDex (Tobramycin
0.3% (3mg) and Dexamethasone 0.1% (1mg)) Sterile Ophthalmic Suspension,
2.5ml sample, 5ml tradesize, 1 ml sample, 10ml tradesize, and 2.5ml tradesize, Rx only, NDC
0065-0647-05
d) Neomycin and
Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension, USP, Each mL
contains Neomycin Sulfate (equivalent to 3.5mg neomycin sulfate base), polymyxin B sulfate 10,000 units, hydrocortisone 10mg,
7.5ml tradesize,
Rx only, NDC 61314-641-75,
e) Ciprodex (ciprofloxacin
0.3% and dexamethasone 0.1%) Sterile Otic Suspension, 7.5ml tradesize, 1.5ml
sample, and 7.5ml sample, Rx only, NDC 0065-8533-02.
CODE
a) Lot numbers: 70020F, 68154F, 71266F, and 71267F
(all 4 lots are samples); 72489F, and 82236F
(both lots are samples);
69081F; 71281F and 70591F; Lot number 86060F distributed only in
Botswana;
b) Lot 70565F and Lot 081663F distributed only in Saudia
Arabia;
c) Lot number: 72950F;
d) Lot number: 70029F;
e) Lot number
70739F; Lot number 72540F distributed only in Canada
RECALLING
FIRM/MANUFACTURER Alcon Research, Ltd, Fort Worth, TX
REASON Lack of
assurance of sterility; leak in the transfer hose of a Vaporous Hydrogen
Peroxide (VHP) generator resulting in reduced amount of VHP used in
decontamination cyle.
VOLUME OF PRODUCT IN COMMERCE 548,869
units
DISTRIBUTION Nationwide, Botswana, Saudi Arabia, and
Canada
PRODUCT
a) Paxil Tablets (paroxetine
HCl) 10 mg, Bottles of 30, Rx only, NDC 0029-3210-13 ----- Also
labeled as
Paroxetine HCl Tablets, 10 mg, Bottles of 30, Rx only
b) Paxil Tablets
(paroxetine HCl) 20 mg, Bottles of 100, Rx
only, NDC 0029-3211-20 ----- Also labeled as
ratio-Paroxetine Tablets, 20mg
c) Paxil Tablets,
(paroxetine HCl), 30 mg, Bottles of 30, Rx only, NDC 0029-3212-13
d) Paxil Tablets
(paroxetine HCl), 40 mg, Bottles of 30, Rx only, NDC 0029-3213-13
CODE
a) Lot # F61-5B10 expiration February 2008
Lot #
1-5Z76 expiration March 2008;
b) Lots # 203-5B11 & 202-5B11 expiration
date 01-31-2008; Lot # 1-5P22 expiration 03/31/07 (distributed only in
Canada);
c) Lots # 503-4B12, F503-4B12, 504-4B12, M504-4B12 & I504-4B12 Expiration Date 12/31/2007;
d) Lots # 702-5B13 & 704-5B13
expiration date 03/31/2008
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Smithkline Beecham Pharmaceuticals, Co., Cidra, PR
Manufacturer: Sb Pharmco Puerto Rico, Inc.,
Cidra, PR.
REASON Superpotent
VOLUME OF
PRODUCT IN COMMERCE 290,704 bottles
DISTRIBUTION Nationwide,
PR, HI, and Canada
PRODUCT Toprol XL 50 mg tablets,
100 count bottles, Rx only
CODE Lot # LF0012 exp
2/29/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca,
Wilmington, DE
Manufacturer: Astra Zeneca, Sodertalje, Sweden,
REASON
Mispackaging: bottles may also contain Toprol XL
100 mg tablets.
VOLUME OF PRODUCT IN COMMERCE 94,776
bottles
DISTRIBUTION Nationwide
PRODUCT
a) Mirtazapine Tablets,
30 mg, 10x10 blister cards and 30 count bottles, Rx only, NDC 0054-8677-25,
b) Mirtazapine Tablets, 45 mg, 30 count bottles, Rx
only, NDC 0054-4678-13
CODE
a) Lot 556066A,
expiration date Feb. 07, Lot 556066B, expiration date Feb. 07;
b) Lot
556247A, expiration date Apr. 07
RECALLING
FIRM/MANUFACTURER Boehringer Ingelheim Roxane, Inc., Columbus, OH
REASON
Dissolution Failure
VOLUME OF PRODUCT IN
COMMERCE 69,913 units
DISTRIBUTION Nationwide
Custom-Rx Compounding Pharmacy Issues Nationwide Recall of Trypan Blue 0.06% Ophthalmic Solution
Custom RX Compounding Pharmacy of Richfield, Minnesota, is initiating a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Use of Trypan Blue which is being recalled should stop immediately.
Trypan Blue was distributed to hospitals and clinics in MD, MN, IL, NE, ND, MI, DC, and PA. This product is intended for ophthalmic use (in the eyes) during cataract surgery.
The solution is dark blue in appearance and is packaged in one cc sterile tuberculin syringes. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The recall includes, but may not be limited to thefollowing lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17.
The pharmacy immediately began notifying customers and/or distributors and working with the Centers for Disease Control (CDC) has called each individual hospital and clinic to arrange for the return, destruction and reimbursement of all recalled product.
For more information on the recall, please contact Verne Betlach with Custom RX Pharmacy at 612-866-2211, 612-810-1363 (mobile) for information.