OCTOBER 2007

WEEK ENDING OCTOBER 6

PRODUCT a) Panocaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP)     Rx Only, 100 CAPSULES, NDC 51991-408-01, 

b) Ultracaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP), 100 CAPSULES, Rx Only, NDC 51991-409-01, 

c) Palcaps 10 Capsules (Pancrelipase Delayed Release Capsules, USP)
    Rx Only 100 CAPSULES, NDC 51991-410-01, 
CODE
a) PCC8eS001;
b) PCC9eS001 (expires Apr 08), PCC9eS002 (expires Aug 08);
c) PCC10eS001 (expires Feb 08), PCC10eS002 (expires Jul 08),
    PCC10eS003 (expires Sep 08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carlsbad Technology Inc., Carlsbad, CA
Manufacturer: Yung Shin Pharmaceutical Industry, Ltd., Tachia, Taiwan, Republic Of China.
REASON Presence of Undeclared Color Additive; product capsule shells contain undeclared FD&C Yellow #5 and Discrepancies between labeled inactive ingredients in the package inserts and the inactive ingredients contained in the products; Some product capsule shells also contain undeclared color additive FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE 30,536 bottles
DISTRIBUTION TN

PRODUCT Octreotide Acetate Injection, 500 mcg/mL (0.5 mg/mL); an Rx subcutaneous injection long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin; 1 mL single dose vial, 10 vials per carton; product number 370701, NDC 63323-377-01, 
CODE Lot number 202500, expiration date 6/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL
Manufacturer: Abraxis Pharmaceutical Products, Melrose Park, IL. 
REASON There is an error on the vial label that incorrectly indicates the product concentration is 0.05 mg/mL octreotide acetate when the actual concentration is 0.5 mg/mL.
VOLUME OF PRODUCT IN COMMERCE 1,490 vials
DISTRIBUTION Nationwide

PRODUCT Terbinafine Hydrochloride Tablets, USP, equivalent to 250 mg base, Rx only, 500 Tablets, NDC 24658-180-05,
CODE Lot I0707102 (Exp. 06/09)
RECALLING FIRM/MANUFACTURER InvaGen Pharmaceuticals, Inc., Hauppauge, NY
REASON Labeling: Terbinafine Hydrochloride Tablets, 250 mg, 500 count bottles, Lot I0707102, were incorrectly labeled as Terbinafine Hydrochloride Tablets, USP
VOLUME OF PRODUCT IN COMMERCE 343 bottles (500 tablets per bottle)
DISTRIBUTION KY

PRODUCT EstroGel® 0.06% (estradiol gel), 24 gram multiple dose pump packaged in papercard carton labeled in part ***Physician Sample***For Topical Use Only***Metered-dose pump capable of delivering fourteen 1.25 gram doses,
CODE Lot 3136 Expiration September 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ascend Therapeutics, Inc., Herndon, VA, 
Manufacturer: Laboratories Besins Iscovesco, Montrouge Cedex, France. 
REASON Mislabeled. Product labeled with incorrect expiration date (September 2009 instead of September 2007)
VOLUME OF PRODUCT IN COMMERCE 27,351 units
DISTRIBUTION Nationwide

WEEK ENDING OCTOBER 13

PRODUCT Zemplar® (paricalcitol) Injection, 5mcg/ml, 1 ml solution in 2mL Fliptop vials, Rx only, NDC 0074-1658-01,
CODE Lots: 46-569-DK, 49-42-DK, and 50-242-DK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Labs, North Chicago, IL, 
Manufacturer: Hospira, Inc., Rocky Mount, NC. 
REASON Mislabeled. Vial labels may be missing printed information including the trade name and the product concentration.
VOLUME OF PRODUCT IN COMMERCE 1.010,400 vials
DISTRIBUTION Nationwide and PR

PRODUCT Citalopram HBr 40 mg, a) 15 count, b) 30 count, and c) 60 count units dose packages, Rx only, 
CODE
a) Batch No. M58329, Lot No. I0612063;
b) Batch No. M58330. Lot No. I0612063;
c) Batch No. M58332, Lot I0612063
RECALLING FIRM/MANUFACTURER
Recalling Firm: PrePak Systems Inc., Cookeville, TN,
Manufacturer: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. 
REASON Unit Dose Mispackaging; Repacked unit dose packages labeled to contain Citalopram 40 mg Tablets actually contain Citalopram 20 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE 4,350 units
DISTRIBUTION TN

PRODUCT
a) Atropine Sulfate Injection USP, (0.1 mg/mL) 1 mg per 10 mL, Single dose Stick-Gard
    Prefilled Syringe, Rx Only, For Intravenous Use, Antimuscarinic; NDC Number: 0548-2039-00,
    Stock Number 2039,
b) Atropine Sulfate Injection USP, (0.1 mg/mL) 1 mg per 10 mL, Luer-Jet Luer-Lock
    Prefilled Syringe, Rx Only, For Intravenous Use, Antimuscarinic, NDC 0548-3339-00,
    Stock Number 3339, 
CODE
a) Lot Number #AS031G5 and #AS032G5;
b) Lot #AS033H5 and Lot #AS036J5.
RECALLING FIRM/MANUFACTURER International Medication Systems, Ltd., S EI Monte, CA, 
REASON Stability Data Does Not Support Expiration. Product fails to maintain full potency to the labeled expiration dates.
VOLUME OF PRODUCT IN COMMERCE 233,055 units
DISTRIBUTION Nationwide

WEEK ENDING OCTOBER 20

PRODUCT FazaClo (clozapine, USP) Orally Disintegrating Tablets 100 mg, each tablet packaged in a child-resistant blister, 100 tablets per box, NDC 68322-002-04, RX, 
CODE Lot: 370522
RECALLING FIRM/MANUFACTURER
Recalling Firm: Azur Pharma, Inc., Exton, PA,
Manufacturer: Catalent Pharma Solutions, LLC, Woodstock, IL. 
REASON Mispacked. Non child-resistant blister packages were packaged in boxes labeled as child-resistant.
VOLUME OF PRODUCT IN COMMERCE 2,748/100 count boxes
DISTRIBUTION Nationwide

PRODUCT Panadol 500 mg Extra Strength Tablets, 60 ct. cartons, Rx only, 
CODE Lot: PA019CB1; Exp Date: 11/15/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glaxo SmithKline, Parsippany, NJ, 
Manufacturer: Glaxo Smithkline, Dungarven, Ireland. 
REASON Mispacked: Panadol 500 ES Caplets 50 ct. bottles were incorrectly packaged in Panadol 500 ES Tablet 60 Ct. Cartons.
VOLUME OF PRODUCT IN COMMERCE 3,425 bottles
DISTRIBUTION PR

PRODUCT Testosterone Cypionate, USP, CIII, packed in 5 grams, 25 grams, 100 grams, 500 grams, 1 kilogram bottles; NDC #s: 38779-0164-3 (5 grams), 38779-0164-4 (25 grams), 38779-0164-5 (100 grams), 38779-0164-8 (500 grams), 38779-0164-9 (1 kilograms) --- For Prescription Compounding. Product is a white or creamy white, crystalline powder, odorless or has a slight odor, and is stable in air, 
CODE Lot 20060901M and 20060901M/x (whereby x represents a letter), exp. 08/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medisca Inc., Plattsburgh, NY,
Manufacturer: Zhejiang Xianju Chemical Pharmaceutical Factory, Chengguan, Xianju,   
China (Mainland). 
REASON Failed USP limit for Free Cyclopentanepropionic Acid.
VOLUME OF PRODUCT IN COMMERCE 44,825 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Sudafed PE Nighttime Nasal Decongestant Tablets (Diphenhydramine
    HCl 25 mg and Phenylephrine HCl 10 mg), 12-tablet carton,
    NDC 0501-2914-12, 
b) Benadryl-D Allergy & Sinus Antihistamine, Nasal Decongestant Tablets
    (Diphenhydramine HCl 25 mg and Phenylephrine HCl 10 mg), 24-tablet
    cartons or trays and 3-24 tablet club cartons, 
CODE
a) Lot 6HB0165;
b) Lots: 6HB0001, 6NB0472, 00837LLN10, 02827LLD04, 01917LLD06,
    01917LLN06, 01917LLN06A, 02217LLD06, 02217LLN06, 02317LLN06, and
    02317LLD06
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 
Manufacturer: Leiner Health Products, Llc, Wilson, NC.
REASON Product failed specification for dosage uniformity and may contain some tablets with lower dose than label amount.
VOLUME OF PRODUCT IN COMMERCE 176,444 packages
DISTRIBUTION Nationwide and PR

WEEK ENDING OCTOBER 27
PRODUCT
a) Ethyl Alcohol, USP, 190 Proof, in plastic bottles, UN1170, DSP-NJ-158 and
    DSP-KY-417, 
b) Ethyl Alcohol, USP, 200 Proof, in plastic bottles, UN1170, DSP-NJ-158 and
    DSP-KY-417, 
CODE
a) Lots: 7120, 7065, 07A1209AN, 06L1203LP, 06L1203LP, 06110829KI, 06H03WB, 06G17WB, 06E30WB, 06E17GB, 06C08GB, 06D26WB, 06E10WB, 06D17GB, 06D06WD, 06K2103K, 06F27WB, 06F13WB, 06F06GB, 06E02WB, 06D17GD, 06C23GB, 06C20WB, 06B14WB, 06B01GB, 06A24WB, 06A186B; 06A03WB, 06G17GB, 05H25WB, 05L15GB, 05J19GB, 05J05WB, 05126GB, 05H15GB, 05G27WB, 05G25PB, 05L12WB, 05L19PB, 05K23WB, 05K08GB, 05K02WB,  05E25GB;
b) Lots: 7179, 7121, 7070, 07A0523; 07B0823, 07A1283, 07A1284, 06H17WA, 06K2823, 06G24GA, 06H07GA; 06F28GA; 06F07GA; 06E09GA, 06C13GA, 06D27GA; 06D05WA, 06D19GA, 06C02GA; 06B13GA, 06B02GA; 06A19GA, 06K1523; 06K0823; 06J05GA; 06J30WA, 06J23GA; 06I06GA, 06A26GA; 05G19QA; 05K03GA; 05K28GA; 05K16PA; 05L28GA; 05L20GA; 05L06WA, 05J10GA; 05J04GA; 05G16QA; 05J13GA; 05H23QA; 05H24GA; 05H08GA;
05G26GA; 05F29GA; 05L06WA, 05G14GA; 05K14GA
RECALLING FIRM/MANUFACTURER EMD Chemicals Inc., Gibbstown, NJ
REASON Product may not meet USP specifications for UV absorbance.
VOLUME OF PRODUCT IN COMMERCE 4,548 bottle 190 proof; 18,318 bottles 200 proof
DISTRIBUTION Nationwide

PRODUCT
a) Prometh with Codeine Cough Syrup, in 4 fl. oz., 8 fl. oz. , and 16 fl. oz. bottles, Each 5 mL contains Codeine Phosphate 10 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%, Rx Only, NDCs 0472-1627-04, 0472-1627-08, and 0472-1627-16, 
b) Prometh with Dextromethorphan Cough Syrup, in 4 fl. oz. and 16 fl. oz. bottles, Each 5 mL contains promethazine hydrochloride 6.25 mg; dextromethorphan   hydrobromide 15 mg. Alcohol 7%, Rx Only, NDC 0472-1630-04, and 0472-1630-16, 
CODE
a) Lot Q02026 with expiration dates 01/2008 and 07/2008;
b) Lot Q02054, Expiration date 07/2008
RECALLING FIRM/MANUFACTURER Actavis Mid-Atlantic, LLC., Baltimore, MD.
REASON Failed Degradation Requirement (promethazine sulfoxide) 9 month stability.
VOLUME OF PRODUCT IN COMMERCE 109,584 bottles
DISTRIBUTION Nationwide