JANUARY 2004

WEEK ENDING JANUARY 17

PRODUCT POTASSIUM ACETATE INJECTION, USP, 100 mEq (2 mEq/mL), FOR IV USE ONLY AFTER DILUTION, Preservative Free, 50 mL,
Single Dose Vial, Rx only. NDC 63323-076-50.
CODE Lot Number 120998, exp. 02-28-05.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, IL.
REASON Non-Sterility Microbial contamination (Bacillus liceniformis).
VOLUME OF PRODUCT IN COMMERCE 21,600 vials.
DISTRIBUTION Nationwide.

PRODUCT TechneScan MAG3, Kit for the Preparation of Technetium Tc 99m Mertiatide, each kit contains 5 reaction vials in a clamshell, each reaction vial contains 1 mg. Betiatide, 0.05 mg. (minimum) Stannous Chloride Dihydrate (SnCl2 2H2O), 0.2 mg. (maximum) Total Tin as Stannous Chloride Dihydrate (SnCl2 2H2O), 40 mg. Sodium Tartrate Dihydrate, and 20 mg. Lactose Monohydrate, Diagnostic for Renal Imaging, Rx Only. NDC NO. 0019-N096-BO.
CODE Lot No. 096-3009.
RECALLING FIRM/MANUFACTURER Tyco Healthcare, Maryland Heights, MO.
REASON Failing radiochemical purity/altered bio-distribution; due to excessive oxygen reducing stannous ion effectiveness.
VOLUME OF PRODUCT IN COMMERCE 6,895 vials (1,379/5-vial kits).
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING JANUARY 24

PRODUCT
a) Stamina-Rx(tm) Tablets, Maximum Sexual Stimulant, a dietary supplement, sold over-the-counter, in bottles of thirty tablets (30) and individual sample packets of two (2) 550 mg tablets labeled to contain a combination of herbal ingredients for use as a sexual stimulant. The primary ingredients (per tablet) listed on the product's labeling include the following: Epimedium Extract (leaves) Yohimbe Extract (bark), (8mg Yohimbine alkaloids), Cnidium Extract (fruit), Xanthoparmelia Scabrosa Extract (lichen), Gamma Amino Butyric Acid, and L-Arginine. The product's labeling recommends a dosage of 1 to 2 tablets prior to sexual activity.
b) Stamina-Rx(tm) for Women Tablets, MAXIMUM SEXUAL ENHANCER, Adult Dietary Supplement, sold over-the-counter, in
bottles of twelve (12) and thirty (30), as well as, sample packets of two (2) 350 mg tablets labeled to contain a combination of herbal ingredients to increase sexual desire, stamina, and arousal. The primary ingredients (per tablet) listed on the product's labeling include the following: Mauria Puama, Epimedum (leaves/stems) 50% Extract, Mucuna Pruriens (seed), Herba Cistanches (root), Xanthoparmelia Scabrosa (lichen), Cnidu Monnier (fruit), Yohimbe 8% (bark), yields 2 mg Yohimbine Alkaloids, Ageratum (root), Gingko Biloba (leaves), and L-Arginine HCL. The product's labeling recommends a dosage of 1 to 2 tablets an hour prior to sexual activity.
CODE
a) Lot #03141220, Expiration May 2005; Manufactured May 2003: Lot #02141484, Expiration August 2005, Manufactured August 2002 and Lot #03141163, Expiration April 2005, Manufactured April 2003. Lot Nos. 141-363, 141-364, 141-365, 141-366, 141-367, 141-368, 141-369, 141-370, 141-444, 141-445, 141-446,141-447 and 141-448.
b) Lot #02143579, Expiration September 2005, Manufactured September 2002.
RECALLING FIRM/MANUFACTURER Hi-Tech Pharmaceuticals, Inc., Norcross, GA.
REASON Unapproved New Drug; product contains undeclared prescription ingredient Tadalafil.
VOLUME OF PRODUCT IN COMMERCE 1 million tablets per lot (4882 Cases (Blister packs)).
DISTRIBUTION Nationwide.

PRODUCT
a) Uroprin( Tablets (502.5 mg Tablet), Dietary Supplement, sold over-the-counter, in bottles of thirty (30) 502.5 mg tablets, labeled to contain a combination of herbal ingredients to increase sexual stamina and arousal. The primary ingredients (per tablet) listed on the product's labeling include the following: L-Arginine, Epimedium 20% Extract (leaf), Tribulus Terrestris 40% Extract (fruit), Xanthoparmelia Scabrosa Extract (lichen), Cnidium Monnier Extract (fruit), Quebracho Extract 8% (bark), Ginkgo Biloba 24/6 (leaf), and L-Arginine Pyroglutamate. Product is packed in clear plastic bottles containing white oblong tablets, with NVE debossed on one side. The product's labeling recommends a dosage of 1 to 2 tablets prior to sexual activity.
b) Cyclovar(tm) Tablets, 60 ct (250 mg. per serving), Pharmaceutical Grade Adult Dietary Supplement, sold over-the-counter, in bottles of sixty (60) 250 mg tablets, labeled to contain a combination of herbal ingredients for the support of erectile dysfunction. The primary ingredients (per tablet) listed on the product's labeling include the following: L-Arginine, Cnidium Monnier Extract, Xanthoparrela Extract, ZMA, Gamma Amino Butyric Acid, Naringen, and Quebracho Extract. Product is packed in clear plastic bottles containing round tablets, white with red speckles, with CYCLOVAR debossed on one side. The product's labeling recommends a dosage of 1 to 2 tablets 45 minutes to an hour prior to sexual activity.
c) Sigra( Tablets, DIETARY SUPPLEMENT, sold over-the-counter, in bottles of thirty (30) 550 mg tablets, labeled to contain a combination of herbal ingredients for the support of sexual activity. The primary ingredients (per tablet) listed on the product's labeling include the following: Epimedium Extract (leaves), Herba Cistanches Extract (root), Xanthoparmelia Scabrosa Extract (lichen), Cnidium Extract (fruit), and Gamma Amino Butyric Acid. Products is packed in clear plastic bottles containing blue hexagonal, film coated tablets, debossed SIGRA on both sides. The product's labeling recommends a dosage of 1 to 2 tablets prior to sexual activity.

d) Spontane-ES(tm) Tablets, Pharmaceutical Grade Adult Dietary Supplement, sold over-the-counter, in bottles of thirty (30) 325 mg tablets, labeled to contain a combination of herbal ingredients for erectile dysfunction. The primary ingredients (per tablet) listed on the product's
labeling include the following: Xanthoparmelia Scabrosa (lichen), Cnidium Monnier (fruit), Quebracho 8 % Extract (bark), Gingko Biloba (leaves), Mucuna Pruriens (seed), and L-Arginine. Product is packed in clear plastic bottles containing blue hexagonal tablets with SPON-TANE debossed on one side and ES on the other The product's labeling recommends a dosage of 1 to 2 tablets an hour prior to sexual activity. CODE
a) Lot #0312683, Expiration March 2005, Manufactured March 2003 and Lot#02126574, Expiration None, Manufactured September 2002.
b) Lot #SNI734, Expiration November 2004, Manufactured November 2002 Lot # SNI 732, expiration November 2004.
c) Lot #02144422, Expiration July 2005, Manufactured July 2002, Lot #02144423, Expiration July 2005, Manufactured July 2002; Lot #02144425, Expiration July 2005, Manufactured July 2002; Lot #02144426, Expiration July 2005, Manufactured July 2002.
d) Lot #02148608, Expiration None, Manufactured September 2002.
RECALLING FIRM/MANUFACTURER National Urological Group, Inc., Norcross, GA.
REASON Unapproved New Drug: tablets contain the undeclared prescription ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE 1 million pills per lot.
DISTRIBUTION Nationwide.

PRODUCT Vigor-Rx Capsules, Pharmaceutical Grade Dietary Supplement, sold over-the-counter, in bottles of sixty (60), 545 and 1002 mg capsules, labeled to contain a combination of herbal ingredients for advanced support of healthy erectile function. The primary ingredients (per capsules) listed on the product's labeling include the following: Maca Extract (root), Muira Puama Extract (root), Epimedium Extract
(leaves/stems), Cnidium Extract (fruit), Xanthoparmelia Scabrosa Extract (lichen), L-Arginine, Erin Tree Extract (bark), Tribulus Extract (fruit), and Forskohlii Extract (root). Packed in clear plastic bottles, containing blue, hard gelatin capsules, marked with three white bands and
VIGOR-Rx The product's labeling recommends a dosage of 1 to 2 capsules 30 to 45 minutes prior to sexual activity.
CODE Lot #0310484, Expiration March 2005, Manufactured March 2003.
RECALLING FIRM/MANUFACTURER National Urological Group, Inc., Norcross, GA.
REASON Unapproved New Drug: tablets contain the undeclared prescription ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE One million capsules (16,666 bottles).
DISTRIBUTION Nationwide.

PRODUCT APAP tablets, (Acetaminophen), 325 mg, 100 count bottles, DIXON'S (Brand Name).
CODE Lot No. 319687 Exp. 03/05 (bottom of bottle).
RECALLING FIRM/MANUFACTURER Magno Humphries, Inc., Tigard, OR.
REASON Mislabeling- bottles labeled to contain 325 tablets actually contain 500 mg acetaminophen caplets.
VOLUME OF PRODUCT IN COMMERCE 504 bottles.
DISTRIBUTION Nationwide.

PRODUCT Unasyn for Injection (ampicillin sodium/sulbactam sodium) 1.5 g equivalent to 1 g ampicillin/0.5g sulbactam, 10 Single Dose ADD-Vantage Vial, For Intravenous use only, Rx Only.
CODE Lot Number/Exp. date: R283A (1 Oct 06).
RECALLING FIRM/MANUFACTURER Pfizer Laboratories, Div Pfizer, Inc., Terre Haute, IN.
REASON Lack of Assurance of Sterility.
VOLUME OF PRODUCT IN COMMERCE 6,629 trays of 10.
DISTRIBUTION Nationwide.

PRODUCT Brite Eyes (Propylene Glycol 0.2% and Polysorbate 80 .2%), LUBRICANT EYE DROPS 15ML, FOR DRY OR IRRITATED EYES.
CODE Lot Numbers: BE23-BE27.
RECALLING FIRM/MANUFACTURER Life Extension Foundation Buyers Club, Inc., Fort Lauderdale, FL.
REASON Misbranding: Product used as labeled may cause burning and other irritation of the eyes.
VOLUME OF PRODUCT IN COMMERCE 19,941 bottles.
DISTRIBUTION Nationwide.

PRODUCT Paraplatin (carboplatin aqueous solution) Injection, 50 mg per vial, 10 mg per mL sterile, 5 mL vials, For IV USE, SINGLE-DOSE VIAL, Rx Only, Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA, NDC 0015-3210-30.
CODE Lot Number/Expiration Date: 3H63625 (1/31/2005).
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Co., New Brunswick, NJ.
REASON Subpotent: (3 month stability).
VOLUME OF PRODUCT IN COMMERCE 28,027 units.
DISTRIBUTION Nationwide.

PRODUCT FLUOXETINE CAPSULES USP, 10mg, 100 count bottles (Aqua Blue/White), Rx Only.
CODE Lot Number/Exp. Date: 106805 (04/04).
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Inc., Northvale, NJ.
REASON Impurities; Total Impurity level exceeded (12 month).
VOLUME OF PRODUCT IN COMMERCE 11,204 bottles.
DISTRIBUTION Nationwide.

PRODUCT Butalbital, Aspirin, and Caffeine Capsules, (50 mg Butalbital, 325 mg Aspirin, 40 mg Caffeine),100 count bottles, Rx only.
CODE Lot number M031552024.
RECALLING FIRM/MANUFACTURER Lannett Co, Inc., Philadelphia, PA.
REASON ANDA/NDA Discrepancies: Manufacturing process used an unapproved source of butalbital.
VOLUME OF PRODUCT IN COMMERCE 4,772 bottles.
DISTRIBUTION Nationwide.

PRODUCT Nardil Tablets (Phenelzine Sulfate Tablets, USP), 15 mg, 100 count bottles, Rx Only.
CODE Lot number/Exp. Date: 90113L (11/2003), 91913L (11/2003), 92513L (12/2003), 92613L (12/2003), 24113L (12/2003), and 24213L (1/2004).
RECALLING FIRM/MANUFACTURER Pfizer Inc., New York, NY.
REASON Subpotent: (stability).
VOLUME OF PRODUCT IN COMMERCE 95,933 bottles.
DISTRIBUTION Nationwide, Canada, Spain, and South Africa.

PRODUCT
a) Antacid (Calcium carbonate, USP 500 mg), 150 count bottles, BARTELL DRUGS Mint Flavor Antacid Regular Strength ANTACID/CALCIUM SUPPLEMENT SODIUM FREE/CALCIUM RICH, The product is also labeled as BARTELL DRUGS Mint Flavor Antacid REGULAR STRENGTH ANTACID/CALCIUM SUPPLEMENT CALCIUM RICH.
b) Antacid Tablets (Calcium Carbonate USP, 750 mg) 96 count bottles, BARTELL DRUGS Tropical Fruit Flavors Antacid EXTRA STRENGTH ANTACID/CALCIUM SUPPLEMENT GREAT TASTE/CALCIUM RICH.
CODE
a) Lot No./Expiration Date: 311476 (1/04), 309854 (11/03), 310566 (3/03), 318093 (1/04), 317253 (1/04);
b) Lot No./Expiration Date: 318125 (1/05), 319441(1/05), 321186(1/05), 322664 (3/05).
RECALLING FIRM/MANUFACTURER Magno Humphries Inc., Tigard, OR.
REASON
a) Misbranding: bottle is incorrectly labeled as containing 200 mg of calcium per serving rather than 400 mg and the percent daily value is incorrectly denoted as 20% rather than 40%;
b) Misbranding: bottle is incorrectly labeled as containing 20% daily value of calcium rather than correctly containing 30% daily value of calcium.
VOLUME OF PRODUCT IN COMMERCE 5,952 bottles.
DISTRIBUTION Nationwide.

PRODUCT Amiodarone HCL Injection, 150 mg/3ml, 50 mg/ml, 10 x 3 mL Single use Vial, Preservative Free, Rx only, FOR IV USE ONLY.
CODE Lot Numbers/Exp Dates: 446102 (06/04), 446103 (06/04), 446104 (07/04), 446105 (06/04), 446106 (10/04), 446107 (10/04), 446110 (10/04), 450470 (10/04), 495013 (11/04), 496062 (11/04), 496799 (11/04), 500104 (11/04), 502519 (02/05), 502522 (02/05), 508688 (06/05).
RECALLING FIRM/MANUFACTURER Bedford Laboratories, Bedford, OH.
REASON The vials contain crystalline particulate matter adhering to the bottom of the glass vials.
VOLUME OF PRODUCT IN COMMERCE 1,084,800 vials.
DISTRIBUTION Nationwide.

PRODUCT Buspar Tablets (buspirone HCl, USP), 15 mg, 60 Dividose tablet and 180 Dividose tablet bottles, Rx Only.
CODE Lot No. 3G74918 Expiration Date: AUG 31, 2006 (60 count bottle) Lot No. 3D68441 Expiration Date: FEB 28, 2005 and 3B63278 Expiration Date: APR 30, 2006 (180 count bottle).
RECALLING FIRM/MANUFACTURER Bristol Myers Squibb Co., C.P.O., Mount Vernon, IN.
REASON Mislabeled: Dosing instructions for the 15 mg Dividose tablet is incorrect in that the diagram for two-thirds of a tablet should denote a 10 mg dose rather than a 15 mg dose.
VOLUME OF PRODUCT IN COMMERCE 39,755 bottles.
DISTRIBUTION Nationwide.

PRODUCT Lithium Carbonate Extended Release Tablets, USP, 300 mg, 100 count bottle, Rx only.
CODE Lot Number/Expiration Date: 403452044T (SEP 2004).
RECALLING FIRM/MANUFACTURER Barr Laboratories, Inc., Forest, VA.
REASON Dissolution Failure: 12 month stability.
VOLUME OF PRODUCT IN COMMERCE 3,165 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING JANUARY 31

PRODUCT Entex LA Capsules (phenylephrine extended release/guaifenesin), phenylephrine HCI extended release 30mg/ guaifenesin immediate release 400mg, NEW FORMULATION, 100 count bottles, Rx only.
CODE Lot numbers: 3785, 3786, 3787, 3788, 3789, and 3814.
RECALLING FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc., Weston, FL.
REASON Mislabeling: Package insert states the color of the capsules as blue and yellow instead of purple and orange.
VOLUME OF PRODUCT IN COMMERCE 46,000 bottles.
DISTRIBUTION Nationwide.