OCTOBER 2005

WEEK ENDING OCTOBER 8

PRODUCT Gemzar (Gemcitabine HCl for Injection) 1 g equivalent to base, for I.V. use only, Sterile Single Use Vial, Rx, Vial No. 7502, NDC 0002-7502-01. 
CODE Lots 8RJ10R, 8RX43M, 8SE75M, 8RX45MA (France) and 8RU85MA (Italy).
RECALLING FIRM/MANUFACTURER Eli Lilly and Company, Indianapolis, IN
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 48,208
DISTRIBUTION Nationwide, France and Italy

PRODUCT Gabapentin Tablets, 600 mg, 100 tablet bottles, NDC 0093-7173-01
CODE Lot #: G04043 Exp. 01/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON Dissolution failure at 3 month test point.
VOLUME OF PRODUCT IN COMMERCE 6,946 bottles
DISTRIBUTION TN

PRODUCT Demulen 1/35 - 28 Tablets (Ethynodiol Diacetate & Ethinyl Estradiol), Each Demulen 1/35 tablet contains: ethynodiol diacetate 1mg, ethinyl estradiol 35 mcg, 6 units of 28 tablets, Each Compack contains: 21 Demulen 1/35 (white) tablets 7 placebo (blue) tablets, Rx only, NDC 0025-0161-09,
CODE Lot # C401110, C400392 and C400827 expiration date in all of them 01/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY,
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR.
REASON Subpotent; Ethinyl Estradiol.
VOLUME OF PRODUCT IN COMMERCE 32,649 units
DISTRIBUTION Nationwide

PRODUCT Lotrimin AF, Antifungal (Miconazole Nitrate 2%), Net wt. 100g (3.5 oz) and 133g (4.6oz), OTC, NDC 11523-1272-1, 
CODE 3B03CC, exp Feb 2006; 4B09CC, exp Feb 2007; 4G03CC, June 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering-Plough HealthCare Products, Inc., Memphis, TN
Manufacturer: Kik Custom Mfg, Cumberland, RI. 
REASON Subpotency: The analytical results for Miconazole Nitrate were below specification for the 12 month stability point.
VOLUME OF PRODUCT IN COMMERCE 479,148 units
DISTRIBUTION Nationwide and Panama

PRODUCT MESALAMINE RECTAL SUSPENSION, USP, ENEMA, 4g/60 mL, For Rectal Use Only, Rx only. Distributed under the Clay Park Labs (CPL) label. NDC 45802-098-51: 7 x 60 mL Unit-Dose Bottles, NDC 45802-098-28: 28 x 60 mL Unit-Dose bottles
CODE 104 batches are being recalled: ML027, ML028, ML029, ML030, ML031, ML032, ML033, ML034, ML035, ML036, ML037, ML038, ML039, ML040, ML041, ML042, ML043, ML044, ML045, ML046, ML047, ML048, ML049, ML050, ML051, ML052, ML053, ML054, ML055, ML056, ML057, ML058, ML059, ML060, ML061, ML062, ML063, ML064, ML065, ML066, ML067, ML068, ML069, ML070, ML071, ML072, ML073, ML074, ML075, ML076, ML077, ML078, ML079, ML080, ML081, ML082, ML083, ML084, ML085, ML086, ML087, ML088, ML089, ML090, ML091, ML092, ML093, ML094, ML095, ML096, ML097, ML098, ML099, ML100, ML101, ML103, ML104, ML105, ML106, ML107, ML108, ML109, ML110, ML111, ML112, ML113, ML114, ML117, ML119, ML120, ML121, ML122, ML123, ML124, ML125, ML127, ML128, ML129, ML132, ML133, ML134, ML135, ML136, ML137. NDC 45802-098-51: UPC bar code # 3 45802-098-51 1; NDC 45802-098-28: UPC bar code # 3 45802-098-28 3. Firm Product Number: 098-51 and 098-28
RECALLING FIRM/MANUFACTURER
Recalling Firm: Clay Park Labs, Inc., Bronx, NY,
Manufacturer: Agis Industries (1983) Ltd., Bnei Brak, Israel. 
REASON Container Leakage: leaking bottles.
VOLUME OF PRODUCT IN COMMERCE 200,000 units
DISTRIBUTION Nationwide

PRODUCT Peroxyl, 35% CG (Cosmetic Grade), 35% Hydrogen Peroxide by weight, meets USP specifications when properly diluted
CODE Lot No. 04E46
RECALLING FIRM/MANUFACTURER Arkema, Inc., Memphis, TN
REASON Failed pH specifications: The firm received a consumer complaint stating that the pH of the product was 2.9 which is above the specification of 2.3-2.8.
VOLUME OF PRODUCT IN COMMERCE 83,700 pounds
DISTRIBUTION Nationwide

PRODUCT Gladase Papain-Urea Debriding Ointment. Labeled in part as "For topical use only, Store in a cool place. Rx only, Product code is 5048410030, NDC 59366-2879-3
CODE Lot numbers: S0403 and S0432
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith and Nephew, Inc., Wound Management Division, Largo, FL
Manufacturer: Stiefel Laboratories Inc., Oak Hill, NY. 
REASON Mislabeling: Incorrect primary tube labeling with respect to the owner of the product. There are no quality or dosing issues involved.
VOLUME OF PRODUCT IN COMMERCE 2,916 tubes
DISTRIBUTION Nationwide

PRODUCT
a) Agua De Alibour (zinc sulfate and copper sulfate) Astringent-Antiseptic liquid packaged in 4 oz. white HDPE cylinder bottle, OTC, UPC code: 758537051049
b) Alcohol Boricado (Boric Acid Alcohol) liquid packaged in either 2 or 4 oz. amber PET Boston round bottles, OTC
c) Alcohol Mentolado (Mentholated Alcohol) liquid packaged in 2 oz. amber PET Boston round bottle, OTC, d) Tincture of Arnica liquid packaged in either 1 oz. or 2 oz. amber PET Boston round bottles, OTC
e) Boric Acid Powder NF Topical Antifungal Agent, 2 oz., 4 oz., and 8 oz. sizes packaged in 4 oz,
225 cc, and 500 cc, respectively, white HDPE Boston round bottles, OTC
f) Eucalyptus Oil Aromatic NF liquid packaged in a 1 oz. amber PET Boston round bottle. OTC,
g) Sodium Bicarbonate USP powder, 4 oz., 8 oz., and 16 oz. sizes packaged in 150 cc, 225 cc,
and 500 cc, respectively, white HDPE Boston round bottles. OTC
CODE All unexpired lots are affected. Products have a six digit lot number with the first two digits representing the year of production, the next two representing the month of production, and the last two being a sequential production number.
RECALLING FIRM/MANUFACTURER Lex, Inc, Medley, FL
REASON Misbranding: Non-compliance with FDA requirements OTC labeling and monograph requirements.
VOLUME OF PRODUCT IN COMMERCE 25,682 cases
DISTRIBUTION Nationwide

WEEK ENDING OCTOBER 15

PRODUCT Prasco Laboratories T-Tanna DM Suspension, Antihistamine/Decongestant Antitussive, Cotton Candy Flavor, Rx Only, 16 fl. oz. (473 mL), NDC 66993-542-57
CODE Batch # GB952
RECALLING FIRM/MANUFACTURER Kiel Laboratories, Inc., Gainesville, GA
REASON Superpotent: Out of specification results.
VOLUME OF PRODUCT IN COMMERCE 1,593 bottles
DISTRIBUTION OH

WEEK ENDING OCTOBER 22

PRODUCT UROCIT-K Potassium Citrate 10, 1080 mg. Tablets (10 mEq per tablet), Rx only, 100 Tablets, NDC 0178-0610-01
CODE Lot Number: 4M113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mission Pharmacal Co., San Antonio, TX
Manufacturer: Mission Pharmacal Co., Boerne, TX. 
REASON Presence of particulate matter: Product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE 14,417 bottles of 100 tablets
DISTRIBUTION Nationwide

PRODUCT Premarin Tablets, (conjugated estrogen), 0.625 mg., 100 tablet bottles, Rx only, NDC 0046-0867-95,
CODE Lot A42766A, exp. date 9/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. 
REASON Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE 29/100 tablet bottles
DISTRIBUTION MO

WEEK ENDING OCTOBER 29

PRODUCT
a) 10% FreAmine III (Amino Acid Injection), 500 mL and 1000 mL Single dose container, Sterile, nonpyrogenic, Rx only, NDA 0264-9011-55
b) 8.5% FreAmine III (Amino Acid Injection) 500 mL Single dose container, Sterile, nonpyrogenic, Rx only,
NDC 0264-9031-55
c) 8.5% FreAmine III (Amino Acid Injection) with Electrolytes, 500 mL and 1000 mL single dose containers,
Sterile nonpyrogenic, Rx only, NDC 0264-1931-10,
d) HepatAmine (8% Amino Acid Injection) 500 mL Single dose container, Steril, nonpyrogenic, Rx only, NDC 0264-9371-55,
CODE
a) 500 mL: Lot #: J4J059, J5B002, J4K011, J4S026 1000 mL: Lot #: J4K018, J4K020, J4K030, J4K037, J4K038;
b) Lot #: J4K010, J4S033, J4N032;
c) 500 mL: Lot #: J4S027, J5C002 1000 mL: Lot #: J5B027;
d) Lot #: J4K014
RECALLING FIRM/MANUFACTURER B. Braun Medical, Inc., Irvine, CA
REASON Product exceeds degradation specification (aluminum) 12 month stability.
VOLUME OF PRODUCT IN COMMERCE 33,240 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Thyro-Tab, .050 mg, Bulk Drum Tablets, For repacking, Rx only
b) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, 100 and 1000 count bottles, Rx only
CODE
a) Bulk: HA27104, HB27104, HC27104, HD27104, and HE27104, all with an expiration date of October, 2005;
b) 100 count bottle: 110409, 110410; 1000 count bottle: 110433, 110434, and 110435 all with an expiration
date of October, 2005
RECALLING FIRM/MANUFACTURER Lloyd Pharmaceutical, Shenandoah, IA
REASON Subpotent (9-month stability)
VOLUME OF PRODUCT IN COMMERCE 9,537,370 bulk tablets; Finished product - 37,610/100-tab. bottles, and 3,792/1,000-tab bottles.
DISTRIBUTION Nationwide

PRODUCT AccuHist PDX Syrup, Each 5mL (teaspoonful) contains: Brompheniramine Maleate, USP 2mg, Detromethorphan HBr, USP 5mg, Phenylephrine HCl, USP 5mg, and Guifenesin, USP 50mg, Alcohol Free, Grape Flavor, 1 pt (473mL) and 30mL bottles, Rx only, NDC 66346-181-65
CODE Lot Nos.: L083M03A, exp 12/05; L087M03A, exp 01/06; L088M03A, exp 01/06; L014B04A, exp 02/06; L069D04A, exp 05/06; L004E04A, exp 05/06; L012H04A, exp 08/06; L017H04A, exp 08/06; L002B05A, exp 02/07; L003B05A, exp 02/07
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, LLC, Huntsville AL
REASON Subpotent; phenylephrine HCl (18 and 24 month stability)
VOLUME OF PRODUCT IN COMMERCE 462,127 units
DISTRIBUTION Nationwide

PRODUCT PREMARIN (conjugated estrogens USP), 0.9 mg, 100-tablet bottles, Rx only, NDC 0046-0864-81
CODE A45568, Exp. 12/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth Pharmaceuticals, Richmond, VA
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. 
REASON Exceeds dissolution specifications (24-month stability)
VOLUME OF PRODUCT IN COMMERCE 99,793 bottles (of which 65,833 to wholesalers)
DISTRIBUTION Nationwide