PRODUCT Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle

MAY 2003

WEEK ENDING MAY 3

PRODUCT Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as --Ancom tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1 mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6. The bottle, unit carton & insert are labeled both in English and Chinese.
CODE All lot codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: Herbsland Incorporated, New York, NY,
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. .
REASON Unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide.
VOLUME OF PRODUCT IN COMMERCE 300 bottles.
DISTRIBUTION NY.

PRODUCT Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as --Ancom tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1 mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6. The bottle, unit carton & insert are labeled both in English and Chinese.
CODE All lot codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: Best Life International, Incorporated, Mayaguez, PR,
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. FDA initiated recall is ongoing.
REASON Unapproved New Drug containing several prescription ingredients.
VOLUME OF PRODUCT IN COMMERCE 591 bottles.
DISTRIBUTION Nationwide

PRODUCT
a) Betamethasone Repository Injection, 6 mg/mL, 2, 5 and 10mL glass vials, Rx.
b) Betamethasone Repository (PF) Injection, 6 mg/mL, 2, 5 and 10mL glass vials, Rx.
CODE
a) Lot Number: 12102002@11, 09172002@1, 10012002@5, 10212002@10, 10282002@8, 11162002@1, 11262002@6,
12192002@19, 01022003@23, 01072003@12, 01102003@3, 01162003@7;
b) Lot Numbers: 01022003@24, 01282003@1.
RECALLING FIRM/MANUFACTURER New England Compounding Center, Framingham, MA,

REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE
a) 4,362 vials;
b) 479 vials.
DISTRIBUTION Nationwide

PRODUCT Necon 0.5/35 Tablets (norethindrone 0.5mg and ethinyl estradiol 35mcg), 6 tablet dispensers, 28 tablets each, Rx only.
CODE Lot 50701D00, Exp April 2003.
RECALLING FIRM/MANUFACTURER Watson Diagnostics, Inc, by letter on January 9, 2003.
REASON Impurities; product exceeds total impurities specification (stability).
VOLUME OF PRODUCT IN COMMERCE 6,366 cartons.
DISTRIBUTION Nationwide.

PRODUCT
a) Methylprednisolone AC (PF) Injection, 80mg/mL 1 ml vial, Rx only.
b) Methylprednisolone AC (PF) Injection, 40mg/mL, 1 mL vial, Rx only.
CODE
a) Lot Codes: 04172002@7, 04112002@8, 03282002@10, 03122002@12, 02272002@8, 02132002@1, 02052002@6, 04292002@5, 05072002@17, 05192002@15, 05232002@3; 05312002@16, 07042002@2;

b) Lot codes: 04182002@1, 06032002@16.
RECALLING FIRM/MANUFACTURER New England Compounding Center, Framingham, MA,

REASON Product labeled with incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
a) 9,551 - 1mL vials;
b) 861 - 1 mL.
DISTRIBUTION Nationwide.

PRODUCT Allegra Tablets, 60/120mg, 60 count bottles, Rx only.
CODE Lot # 3B1250BA EXP 5/2004 Lot # 3B1250BB EXP 5/2004.
RECALLING FIRM/MANUFACTURER Recall by: Direct Dispensing, Inc., Miami, FL,

Manufactured by: Aventis Pharmaceuticals, Kansas City, MO.
REASON Mislabeled (by repacker); bottle labeled to contain Allegra actually contains Allegra-D (fexofenadine/pseudoephedrine HCl).
VOLUME OF PRODUCT IN COMMERCE 56 bottles.
DISTRIBUTION Nationwide.

PRODUCT Carisoprodol Tablets, USP, 350mg, 500 and 1000 tablet bottles.
CODE 1,000 tablet bottles -- 210049A exp. 9/04; 210050A exp. 9/04; 500 tablet bottles -- 210051A exp. 9/04; 210052A exp. 9/04; 210053A exp 10/04.
RECALLING FIRM/MANUFACTURER Able Laboratories, Inc., South Plainfield, NJ,

REASON Incorrect tablet imprinting; some tablets bear the incorrect identification "A265" rather than "A266".
VOLUME OF PRODUCT IN COMMERCE 7,731 bottles.
DISTRIBUTION Nationwide.

PRODUCT Premarin Tablets (Conjugated Estrogens Tablets, USP) 1.25 mg, 100 count bottles, Rx Only.
CODE 1D00076, Exp. 08/03.
RECALLING FIRM/MANUFACTURER Recalled by: Amerisource Health Services, Corp., Columbus, OH,
Manufacturer: Ayerst Laboratories Inc., A Wyeth-Ayerst Company, Philadelphia, PA.
REASON Dissolution failure (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE 449 bottles of 100 tablets.
DISTRIBUTION Nationwide.

WEEK ENDING MAY 24

PRODUCT Nicotine Polacrilex Gum USP, 4 mg (Active ingredient (in each piece) 4 mg nicotine), STARTER KITS (each carton contains 108 Chewing Pieces in blister packs) and REFILL KITS (each carton contains 48 Chewing Pieces in blister packs)--- Distributed under the following private labeling: ----CVS pharmacy brand, POLACRILEX GUM USP, NICOTINE 4 mg, ORIGINAL, ---- Rugby brand, nicotine polacrilex gum, USP, 4 mg (nicotine, ---- Walgreens brand, Nicotine Gum 4 mg, nicotine polacrilex, USP, --- LEADER brand, Nicotine Gum, Nicotine Polacrilex Gum USP, 4 mg (nicotine).
CODE Lot numbers: 4NG02021-Exp Date 07/01/2004; 4NL02133-Exp Date 11/01/2004.
RECALLING FIRM/MANUFACTURER Watson Diagnostics, Inc., Corona, CA,
REASON Contamination: pieces of latex gloves were found in the gum.
VOLUME OF PRODUCT IN COMMERCE 19,853 cartons (total for both lots).
DISTRIBUTION Nationwide.

PRODUCT Oxygen Compressed USP, E cylinders.
CODE Lot V01Q007B.
RECALLING FIRM/MANUFACTURER Hammer Medical Supply, Inc., Des Moines, IA,
REASON A portion of the lot was released as unfilled cylinders by the contract manufacturer (Airgas-North Central).
VOLUME OF PRODUCT IN COMMERCE 35 cylinders.
DISTRIBUTION IA.

PRODUCT Bite Out, cream hydrocortisone, 1 %, 1 oz jars, Made in the U.S.A. Exclusively for: Tangled Vine, Shell Knob, MO.
CODE Lot # 3940 MFD 07/02.
RECALLING FIRM/MANUFACTURER Vita-Erb Ltd., Springfield, MO,
REASON Subpotency and failure to manufacturer product under Good Manufacturing Practice Regulations.
VOLUME OF PRODUCT IN COMMERCE 78/1 oz. jars.
DISTRIBUTION MO.

PRODUCT Pro Pam, Liquid, Pinworm Treatment, Pyrantel Pamoate base 50mg/ml, 2, 8, 16, and 32 fl. Oz. containers.
CODE Lot numbers 7501 through 7519.
RECALLING FIRM/MANUFACTURER Protec Laboratory, Division of SSB Holdings, Inc, Belton, TX, .
REASONFailure to manufacture under Good Manufacturing Practices including, but not limited to, lack of batch production records.
VOLUME OF PRODUCT IN COMMERCE 503 gallons

DISTRIBUTION TX

PRODUCT a) Levothroid Tablets (levothyroxine sodium tablets, USP), 25 mcg., 100-tablet bottles, FOREST, Rx Only.
b) Levothroid Tablets (levothyroxine sodium tablets, USP), 175 mcg., 100-tablet bottles, FOREST, Rx Only.
CODE
a) Lot 40245, Exp 05/2004;
b) Lot 5023, Exp. 05/2004; Lot 5024, Exp. 05/2004.
RECALLING FIRM/MANUFACTURER Forest Pharmaceuticals, Inc., Earth City, MO,
REASON Contamination; tablets contain trace levels of the solvent isophorone.
VOLUME OF PRODUCT IN COMMERCE
a) 14,131 bottles;
b) Lot 5023 - 12,398 bottles; Lot 5024 - 9,192 bottles.
DISTRIBUTION Nationwide.

PRODUCT a) Liposyn II 10%, Intravenous Fat Emulsion, 500 mL single dose containers, Rx only.

b) Liposyn II 20%, Intravenous Fat Emulsion, 200 mL and 500 mL single dose containers, Rx only,
c) Liposyn III 10%, Intravenous Fat Emulsion, 500 mL single dose containers, Rx only.
d) Liposyn III 20% Intravenous Fat Emulsion, 500 mL single dose containers, Rx only.
e) Liposyn III 30%, Intravenous Fat Emulsion, 500 mL single dose glass bottle, Rx only, Pharmacy Bulk Package, Not for Direct Infusion ;
f) Propofol Abbott Injection, 10 mg/mL, 20mL, 50mL, 100mL vials and 20 mL Ampoules, Emulsion for IV Injection or Infusion Sterile, Abbott Laboratories, North Chicago, IL 60064 Also sold as: Propofol Injection, 200mg/20mL, Abbott Australasia PTY LYD, Kurnell 2231 Australia,
Abbott Laboratories (NZ) LTD, Naenae Lower Hutt New Zealand Propofol Emulsion Inyectable I.V., 10 mg/mL, 500mg en 50 mL vial, Manufacturado por: Abbott Laboratories, North Chicago, IL 60064, USA Propofol Injection/Injectable, Abbott Laboratories Limited,
Laboratoires Abbott Limitee, Saint-Laurent, Qc H4S 1Z1 Propocam, Propofol.Emulsion Inyectable, 200mg, Fabricado en Estados Unidos por: Abbott Laboratories North Chicago, IL, Acondicionado y distribuido en Mexico por; Abbott Laboratories de Mexico SA de CV Av Coyoacan No 1622, Col del Valle CP 03100, Mexico Propofol Medicamento Generico Lei, 10 mg/ml, 5 frascos-ampola de 20 ml, Abbott Laboratories do Brasil Ltda PropoFlo, propofol Ph Eur 10 mg/ml, 20 ml vials, injectable anaesthetic for dogs and cats, Manufactured for: Abbott Laboratories, Queenborough, Kent ME11 5EL, By Abbott Laboratories, North Chicago, IL.
CODE
a) Lot 85396DE;
b) Lots 85394DE; 85393DE (200mL); Lots 84363DE, 84364DE, 85385DE, 85390DE, 85400DE, 84362DE, 85399DE (500mL).
c) Lot 85389DE;
d) Lots 84365DE, 84374DE, 84378DE, 85384DE, 85387DE, 85388DE, 85397DE, 85398DE, 85401DE;
e) Lot 84381DE;
f) Lots 84850Z7, 85718Z7, 84851Z7, 84839X7, 85712Z7, 85715Z7, 85726Z7, 84843Z7, 85711Z7, 85714Z7, 85717Z7, 84849Z7, 84842Z7, 85710Z7, 85724Z7, 85725Z7, 84841Z7, 84959Z7 (vet product).
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL, .
REASON Contaminated, product contains stainless steel particles.
VOLUME OF PRODUCT IN COMMERCE 157,164 bottles; 449,520 vials.
DISTRIBUTION Nationwide, and Canada, Singapore, Thailand, Turkey, Lithuania, Bosnia, Pakistan, Australia, Mexico, Malaysia, Hong Kong, Malta, Croatia, Bulgaria, Brazil, England, Italy. Please Note: The Propofol products were not distributed in the US.

PRODUCT Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 300mcg, 100 and 1,000 tablet bottles, J P Jones, Rx only.
CODE 300 mcg, 100 tablet bottle: Lot Nos.: 7325 (Exp date 07/03), 7483 (09/03), 7484 (09/03), 7776 (01/04) 300 mcg, 1,000 tablet bottles: Lot Nos. 7325 (Exp date 7/03), 7484 (9/03), 7775 (1/04).
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN,
REASON Subpotency; during stability testing.
VOLUME OF PRODUCT IN COMMERCE 84,844 units.
DISTRIBUTION Nationwide.

PRODUCT Senokot-S Tablets (Docusate sodium 50mg and Sennosides 8.6mg) Natural Vegetable Laxative plus Softener, Standardized Senna Concentrate and Docusate Sodium, blisterpack of 4 tablets, Professional Samples: Not for Sale.
CODE Lot JV31, Exp. 01/04; Lot JV41, Exp. 01/04; Lot MA11, Exp. 06/04.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT,
REASON Mislabeled; Labeling does not indicate dosage instructions for children under 2 years of age.
VOLUME OF PRODUCT IN COMMERCE 924,279.
DISTRIBUTION Nationwide.

PRODUCT Liquid Oxygen USP, 45 liter in home cryogenic vessels.
CODE Serial numbers (vessels): 6089918017, 590001035, 599720020, 599726024, 599725054, 599640003, 599640005, 590001037, 599725060, 599911021, 599950056, 599640004, 599719023, 599739086, 599640002, 599720119, 590136019, 599738091, 599950004, 590136016, 599720116, 599726026.
RECALLING FIRM/MANUFACTURER Olympic Pharmacy & Healthcare, Gig Harbor, WA,
REASON GMP deviations, including but not limited to, failure to maintain records of testing for purity, strength, and identity.
VOLUME OF PRODUCT IN COMMERCE 22 vessels.
DISTRIBUTION WA.

PRODUCT a) Fiber Tabs (Calcium polycarbophil) 625mg equivalent to 500mg polycarbophil, 250 caplet count bottles, Bulk-
Forming Fiber Laxative, Kirkland Signature brand.
b) Fiber Caplets (Calcium polycarbophil) 625mg equivalent to 500mg polycarbophil, 250 caplet count bottles, Bulk-Forming Fiber

Laxative 1-3;
c) Fiber Lax Caplets (Calcium polycarbophil) 625mg equivalent to 500mg polycarbophil, 90 count bottles, Bulk-Forming Fiber Laxative.
CODE
a) Lot number 2HA0654;
b) Lot numbers: 2HA0768, 2HA0905 and 2HA0651;
c) Lot number: 2HA0652.
RECALLING FIRM/MANUFACTURER Leiner Health Products, Carson, CA,

REASON Tablet mixup; bottles may contain acetaminophen tablets (500mg).
VOLUME OF PRODUCT IN COMMERCE 15,454 bottles.
DISTRIBUTION Nationwide.

PRODUCT Methocarbamol Tablets USP, 500 mg, 100 and 500 tablet bottles, Watson, Rx Only.
CODE
a) C2L1076, Exp. 12/31/2004;
b) C2K1014, Exp. 12/31/2004.
RECALLING FIRM/MANUFACTURER Watson Pharmaceuticals, Inc., Corona, CA,
REASON Dissolution Failure; 3 month stability sample.
VOLUME OF PRODUCT IN COMMERCE
a) 1,960 bottles;
b) 21,643 bottles
DISTRIBUTION Nationwide.

PRODUCT Enalapril Maleate Tablets, USP, 10 mg, bottles of 1000, TEVA, Rx only.
CODE Lot # 15741 exp 5/31/03.
RECALLING FIRM/MANUFACTURER Teva Pharmaceuticals USA, North Wales, PA,
REASON Degradation: Related compound specification failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 1,182 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING MAY 31

PRODUCT Ancom Tablets (Anti-Hypertensive Compound Tablets), 100 count bottles, Manufactured by SHANGHAI PHARMACEUTICALS INDUSTRY CORP. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as - Ancom Tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6 1 mg. The bottle, unit carton & insert are labeled both in English and Chinese.
CODE All lots
RECALLING FIRM/MANUFACTURER Tai Chien, Inc., New York, NY,
REASON Unapproved New Drug containing prescription ingredients
VOLUME OF PRODUCT IN COMMERCE 1,850 units.
DISTRIBUTION NY and Puerto Rico.

PRODUCT Sarapin Injection, Pitcher Plant, 50 ml Multiple Dose Vial, Sterile aqueous solution of soluble salts of the volatile bases.
CODE Lot number - 205722 (Exp. Date 05/2005); Lot number - 205825 (Exp. Date 05/2005); Lot number - 206824 (Exp. Date 06/2005).
RECALLING FIRM/MANUFACTURER High Chemical Co, Levittown, PA,
REASON Lack of assurance of sterility (by manufacturer-Akorn, Inc.)
VOLUME OF PRODUCT IN COMMERCE 38,571 vials.
DISTRIBUTION Nationwide, Canada, Switzerland, Bulgaria, and the Netherlands.

PRODUCT Lioresal Intrathecal Refill Kits, Model 8562, (baclofen injection), 10mg/5mL (2000 mcg/mL), 2-5 mL ampules per kit, refill kit/drug prep kit, Rx only.
CODE Lot number B03001710N, Exp. Date 03 Feb 05.
RECALLING FIRM/MANUFACTURER Medtronic, Inc, Minneapolis, MN,
REASON Lack of assurance of sterility - cracks in refill kit tray (gloves, needles, filter, etc., not drug or drug prep kit).
VOLUME OF PRODUCT IN COMMERCE 68 kits.
DISTRIBUTION Nationwide.

PRODUCT Erythromycin, USP Base, Dihydrate, Code No. 79147, bulk drug (drum), Caution: For Manufacturing, Processing or Repacking, Rx Only.
CODE Lot 72332CD00, Exp.12/13/05.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, North Chicago, IL,
REASON Failure of x-ray identification limit for monohydrate form.
VOLUME OF PRODUCT IN COMMERCE Portion of one lot to a single manufacturer
DISTRIBUTION NY.

PRODUCT a) Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25mg, bottles of 100, Rx only.
b) Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 5 mg/6.25mg, bottles of 100, Rx only.
c) Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 10mg/6.25mg. bottles of 30, Rx only.

CODE a) Lot No. 306M11 Exp Date 1/03; 460F21 Exp Date 10/03;481C11 Exp Date 9/03; 575H11 Exp Date 5/03; 576H11 Exp Date 5/03; 870D21 Exp Date 5/03; 871D21 Exp Date 11/03; 872D21 Exp Date 11/03; 966E11 Exp Date 6/03; 967E11 Exp Date 6/03;
b) Lot No. 307M11 Exp Date 1/04; 308M11 Exp Date 1/04; 309M11 Exp Date 1/04; 361B11 Exp Date 3/03; 362B11 Exp Date 3/03; 482C11 Exp Date 3/03; 483C11 Exp Date 3/03; 577H11 Exp Date 10/03; 578H11 Exp Date 10/03; 873D21 Exp Date 5/04; 874D21 Exp Date 5/04; 875D21 Exp Date 5/04; 876D21 Exp Date 5/04; 968E11 Exp Date 6/03; 969E11 Exp Date 8/03;
c) Lot No. 310M11 Exp. Date 1/04; 363B11 Exp. Date 3/03; 579H11 Exp. Date 9/03; 580H11 Exp. Date 9/03; 877D21 Exp. Date 5/04; 878D21 Exp. Date 5/04; 879D21 Exp. Date 5/04; 970E11 Exp. Date 6/03.
RECALLING FIRM/MANUFACTURER Alpharma Purepac, Elizabeth, NJ,
REASON Impurity failure; product failed to meet the Bisoprolol Fumarate unknown impurity specification.
VOLUME OF PRODUCT IN COMMERCE 756,230 bottles.
DISTRIBUTION Nationwide.