SEPTEMBER 2003

WEEK ENDING SEPTEMBER 6

PRODUCT INFANT 4.2% Sodium Bicarbonate Injection, USP, 5 mEq (0.5 mEq/mL), 10 mL unit of use syringe, LifeShield, Glass Abboject, Rx only.
CODE Lot number 95-257-DK, Expiration date December 1, 2004.
RECALLING FIRM/MANUFACTURER Abbott Labs, North Chicago, IL.
REASON Mispacked; A correctly labeled vial of 10% Calcium Chloride Injection, USP was incorrectly packed in a carton labeled as Infant 4.2% Sodium Bicarbonate Injection, USP.
VOLUME OF PRODUCT IN COMMERCE 45,800 syringes.
DISTRIBUTION Nationwide and Canada.

PRODUCT Pain Relieving Rub, (Menthol 10% and Methyl salicylate 15%), Greaseless/Stainless Analgesic Cream, Net Wt. 4 oz (114 g) tubes, Manufactured by G & W Laboratories, Inc., South Plainfield, NJ. Also sold under other brand names as
---- Greaseless Pain Relieving Rub, Greaseless/Stainless Analgesic Cream, Distributed by: Happy Harry's, Inc., Newark, DE.
---- Muscle Rub, Greaseless Pain Relieving Cream, Distributed by Drug Guild Distributors, Inc., Glen Rock, NJ.
---- Pain Relieving Rub, Greaseless/Stainless Analgesic Cream, Distributed by Ingles, Asheville, NC.
---- Pain Relieving Cream, Greaseless, Distributed by Navarro Distribution Center, Inc., Miami, FL.
---- Muscle Rub, Distributed By: Kerr Drug Inc., Durham, NC
---- Muscle Rub, Greaseless, Stainless, Pain Relieving Rub, Distributed by: Select Brand Distributors, Pine Bluff, AR.
CODE
Lot No/Exp. Date:
2087-2 Exp. 04/2004;
2139-9 Exp. 05/2004;
2140-2 Exp. 06/2004;
2159-2 Exp. 06/2004;
2204-1 Exp. 08/2004;
2220-1 Exp. 08/2004;
2270-3 Exp. 10/2004.
RECALLING FIRM/MANUFACTURER G & W Labs, Inc., South Plainfield, NJ.
REASON Subpotent (methyl salicylate) 12 month stability.
VOLUME OF PRODUCT IN COMMERCE 24,315 tubes.
DISTRIBUTION Nationwide.

WEEK ENDING SEPTEMBER 13

PRODUCT
a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count bottles and 4 tablet sample packets, Each tablet contains: Ginseng-40mg, Oat straw-10mg, Mauria puama-10mg, DHEA-10mg, Saw palmentto-40mg, Tribulus terrestris-40mg, Yohimbe extract-40mg, and Androstenedione-10mg.

b) Viga for Women tablets, BEST LIFE, 20 tablet bottles, Ingredients: Mauria Puama, Ginseng, Maca, Wild Yam, DAmiana, L-Argining, Dong Qual., Guarana, Horney Goat Weed, and Macuna Prurions Extract.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: RMA Laboratories, Inc., Paramount, CA.
Manufacturing Firm: Health Nutrition Inc., Torrance, CA. and/or Best Life International, Inc. Firm initiated recall is ongoing.
REASON Unapproved New Drug; product contains undeclared prescription drug Sildenafil.
VOLUME OF PRODUCT IN COMMERCE Approx. 6 million tablets.
DISTRIBUTION Nationwide.

PRODUCT
a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count bottles and sample packets of 4 tablets, Ingredients: Ginseng, Oat straw, Melria puama, DHEA, Saw palmentto, Tribulus, Yohimbe, and Androstenedione, Inc.
b) Viga for Women tablets, 20 count bottles, (Natural Stimulant), Ingredients: Mauria Puama, Ginseng, Maca, Wild Yam, DAmiana, L-Argining, Dong Qual., Guarana, Horney Goat Weed, and Macuna Prurions Extract.
CODE
a) Catalog numbers 10725 All Lots.
b) Catalog numbers 10728 All Lots.
RECALLING FIRM/MANUFACTURER Best Life International Inc., Mayaguez, PR.
REASON Unapproved New Drug; product contains the undeclared prescription drug ingredient Sildenafil.
VOLUME OF PRODUCT IN COMMERCE 29,992 bottles.
DISTRIBUTION Puerto Rico.

PRODUCT VINAROL with VASX Tablets, 500mg, blister packages of 2 or 7 tablets, Each tablet contains a proprietary blend of Cassia Tree, Dodder Seed, Epimedium, Wolfbery, Saling, Cistanche, Mangolia Vine Fruit, Red Raspberry, Narrow Leaved Polygala, Rehmannia Root, Eucommia Bark, Hindo Lotus Seed, Bidemate Bark, Milk Vetch Seed, Cherokee Rose, Arborviate Seed, American Ginseng, Ginko Bilboa, Bionate International, Inc. Phoenix, AZ.
CODE
Lot 030060 Exp 11/2006 thru 3/2007;
Lot 020245 Exp 11/2006 thru 3/2007.
RECALLING FIRM/MANUFACTURER Bionate International, Inc., Scottsdale, AZ.
REASON Unapproved New Drug; product contains undeclared prescription drug sildenafil.
VOLUME OF PRODUCT IN COMMERCE 1-6 million tablets.
DISTRIBUTION Nationwide.

PRODUCT Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 112 mcg, 100 count bottles, Rx only, Repackaged by: American Health Packaging, Columbus, OH, NDC 52604-5112-1.
CODE Lot #024737, Exp. May 31,2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Health Packaging, Columbus, OH.
Manufacturing Firm: Jones Pharma Inc, (A wholly owned subsidiary of King Pharmaceuticals, Inc.), St. Louis, MO.
REASON Tablet mix-up: bottles labeled as Levoxyl 112mcg tablets were found to contain Soloxine 0.2mg tablets (Vet/Animal brand-Levothyroxine).
VOLUME OF PRODUCT IN COMMERCE 4,218 bottles.
DISTRIBUTION Nationwide.

PRODUCT Sporanox Injection Kit (Itraconazole), 10mg/mL, 25mL ampule, One Unit Dose Ampule per kit, Rx only, NDC 50458-298-01 (kit).
CODE 02F03AIW (02/04); 02F04AIW (02/04); 02G01AZ7 (04/04); 02H02AZ7 (04/04); 02J01AZ7 (02/04) 02J02AZ7 (02/04); 02J03AZ7 (05/04); 02J03BZ7 (05/04) 02L02AZ7 (07/04); 02L03AZ7 (07/04); 02L04AZ7 (08/04).
RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho Biotech Products LP, Raritan, NJ.

Manfacturing Firm: Abbott Laboratories, North Chicago, IL.
REASON Discoloration; incorrect connector piece included in the Abbott Microbore Extension Set/Kit may become discolored.
VOLUME OF PRODUCT IN COMMERCE 60,000 kits.
DISTRIBUTION Nationwide, Germany and Israel.

PRODUCT Trionate Suspension (Each 5 mL (one teaspoon full) contains: Carbetapentane Tannate, 30mg and Chlorphentramine Tannate, 4mg), RX only, Net Contents: 16 fl. oz. (one pint) 473 mL, NDC 51991-071-16.
CODE L021261, L021J011 and L02L111.
RECALLING FIRM/MANUFACTURER Recalling Firm: Breckenridge Pharmaceutical Inc., Boca Raton, FL.
Manufacturing Firm: Unigen Pharmaceuticals, Inc. Westminster, MD. Firm initiated recall is complete.
REASON Contamination; product complaints of black particulates and/or mold, appearance changes and "off" taste.
VOLUME OF PRODUCT IN COMMERCE 4,242 bottles.
DISTRIBUTION Nationwide and Puerto Rico.

WEEK ENDING SEPTEMBER 27

PRODUCT Sodium Nitroprusside Injection, 50 mg/2mL single dose vial, For Intravenous Infusion Only, Rx only. Baxter Mfd. for an affiliate of Baxter Healthcare Corp., Deerfield, IL.
CODE 00K113, exp 08/03; 00N107, exp 10/03; 00S110, exp 12/03; 01B117, exp 02/04; 01H101, exp 06/04; 02A127, exp 01/05; 02C112, exp 03/05; 02E104, exp 05/05; 03C119, exp 03/06.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Anesthesia and Critical Care, New Providence, NJ.
Manufacturer: Gensia Sicor Pharmaceuticals, Inc, Irvine, CA.
REASON Particulates .
VOLUME OF PRODUCT IN COMMERCE 1,146,805 vials.
DISTRIBUTION Nationwide.

PRODUCT Kaletra Capsules (lopinavir/ritonavir) capsules, Each soft gelatin capsule contains: Iopinavir 133.3mg, ritonavir 33.3mg, 180 Capsules bottles, Rx only, Abbott Laboratories, North Chicago, IL.
CODE Lot No. 852072E25, Expiration Date June 2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Morris Dickson, Shreveport, LA.

Manufacturer: Unknown.
REASON Counterfeit; bottles labeled as containing Kaletra Capsules may contain Kaletra Capsules and/or Agenerase Capsules or a mix of both, as well as, bottles of Kaletra Capsules have been repackaged/relabeled by an unknown source with an extended expiration date/counterfeit lot number.
VOLUME OF PRODUCT IN COMMERCE 58 bottles of 180 capsules.
DISTRIBUTION Nationwide.

PRODUCT Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol), 16.2 g. canister, 104 metered actuations, FOR ORAL INHALATION ONLY WITH ACCOMPANYING MOUTHPIECE. Mfd. for Aventis Pharmaceuticals Respiratory Products, Bridgewater, NJ. .
CODE A30007A, Exp. Jan 2005.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Pharmaceuticals, Inc., Kansas City, MO
Manufacturer: Fisons Limited, Holmes Chapel CW488E, Great Britain. Firm initiated recall is ongoing.
REASON Container Defect: Misplaced side holes on metering valve stems causing a lower dosage delivery to patient.
VOLUME OF PRODUCT IN COMMERCE 14,111 canisters.
DISTRIBUTION Nationwide.

PRODUCT Mylanta Antacid Anti-Gas (Aluminum Hydroxide equivalent to dried gel, USP 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg) 5 Fl Oz (150ml) bottles.
CODE Lot number HDF041.
RECALLING FIRM/MANUFACTURER Recalling Firm: Johnson & Johnson Merck, Fort Washington, PA.
Manufacturer: Johnson & Johnson Merck, Lancaster, PA. Firm initiated recall is ongoing.
REASON Defective container, tamper evident cap does not engage properly.

VOLUME OF PRODUCT IN COMMERCE 24,360 bottles.
DISTRIBUTION Nationwide, Trinidad and Tobago.

PRODUCT Zemuron Injection, (rocuronium bromide) 10 mg/mL, For IV use only, professional sample of 6X5mL vials, 5mL and 10mL multiple dose vials.
CODE Packaged Lot Numbers: 2442902450, exp. July 2004; 2453002450, exp. July 2004; 2463102450, exp. July 2004; 0583102450, exp. July 2004; 0593302450, exp. July 2004; 2483702450, exp. August 2004; 2493702450, exp. August 2004; 0023702450, exp. August 2004; 2513802450, exp. August 2004; 2623802450, exp. August 2004; 0634002450, exp. August 2004; 0644002450, exp. August 2004; Packaged Lot Numbers: 1483402450, exp. August 2004; 1493502450 exp. August 2004; 1503602450, exp. August 2004. The packaged lot number has an additional three digit packaging before the manufactured lot number.
RECALLING FIRM/MANUFACTURER Organon, Inc., West Orange, NJ.
REASON Vials may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE 1,582,420 vials.
DISTRIBUTION Nationwide and Canada.