JULY 2003

WEEK ENDING JULY 12

PRODUCT Metformin HCI, bulk drug powder, 50.0 Kg drums, for manufacturing, processing or repacking.
CODE Lot #s: 202701MF1, 203601MF1, 203001MF1.
RECALLING FIRM/MANUFACTURER ChemSource, Corp., Guayama, PR.
REASON Cross-Contamination; product contains Etodolac.
VOLUME OF PRODUCT IN COMMERCE 3,689.5 kg.
DISTRIBUTION WV and Canada.

PRODUCT Budesonide BP Micronized, 500mg, 5g, 1g, 25g, 100g bottles, Caution: For manufacturing, processing and repackaging.
CODE Lot numbers: 03100205, 03100206, 03100207, 03100208, 03100209, and 03200307.
RECALLING FIRM/MANUFACTURER Meridian Pharmaceuticals, Inc., Decatur, AL.
REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE 276 grams.
DISTRIBUTION Nationwide.

PRODUCT Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL, 473 mL (1 pint) syrup, Rx only.
CODE Lot 20920.
RECALLING FIRM/MANUFACTURER Schwarz Pharma Manufacturing, Seymour, IN.
REASON Mislabeled; front label incorrectly states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL.
VOLUME OF PRODUCT IN COMMERCE 393 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Coppertone_ Bug & Sun Sunscreen with Insect Repellent, (N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ (237mL) bottles.
b) Coppertone_ Bug & Sun Sunscreen with Insect Repellent, (N,N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 8 FL OZ (237mL) bottles.
CODE
a) 2D01PM, 2P02PM, and 3A01PM;
b) 1J01PM, 1M05PM, 1M01PM, 1M06PM, 1M05PM, 1M05APM, 1M04PM, 1N01PM, 1N06PM, 1N05PM, 1N04PM, 1N03PM,
1N02PM, 2A08PM, 2A04PM, 2A03PM, 2A02PM, 2A01PM, 2D03PM, 2E01PM, 2H01PM, 2J02PM, 2J01PM, 2K03PM,
2K02PM, 2K01PM, 2M01PM, 2N01PM, 2P01PM, 3A04PM, 3A02PM, 3B06PM, 3B01PM, 3B05PM, 3B04PM, 3B03PM,
M312005/3B06PM, M312005A, M312005B, M312105, 3C02PM, 3C01PM, and 3C03PM.
RECALLING FIRM/MANUFACTURER Schering-Plough Health Care Products/DBA Bain deSoleil, Co., Cleveland, TN.

REASON
a) Incorrect inactive ingredient; product contains Benzophenone-4 rather than Benzophenone-3;
b) Product contains undeclared preservative.
VOLUME OF PRODUCT IN COMMERCE 902,519 units.
DISTRIBUTION Nationwide.

PRODUCT Lisinopril Tablets Usp, 10 mg, 10 tablet bottles, Sample Not To Be Sold.
CODE Lot # 117955.
RECALLING FIRM/MANUFACTURER Recalling Firm: Nucare Pharmaceuticals, Inc., Orange, CA.
Manufacturer: Ivax Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON Mislabeling; product label does not contain Rx only legend.
VOLUME OF PRODUCT IN COMMERCE 3,600 bottles.
DISTRIBUTION CA.

PRODUCT Premarin Tablets (conjugated estrogens tablets, USP), 1.25 mg, 100 and 1000 tablet bottles, Rx only.
CODE Lots: #9000073B (100s) and #9000073W (1000s). Exp. Date on both lots is 07/04.
RECALLING FIRM/MANUFACTURER National Pharmpak Services, Inc., Zanesville, OH.
Manufacturer: Ayerst Laboratories, Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall is ongoing.
REASON Dissolution failure by manufacturer (Wyeth)
VOLUME OF PRODUCT IN COMMERCE 34,378 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING JULY 19

***CORRECTION***

Coppertone Bug & Sun states that the reasons for the recall are:
a) Incorrect inactive ingredient; product contains Benzophenone-4 rather than Benzophenone-3;
b) Product contains undeclared preservative.
Preferred wording is:
a) These lots contain trace quantities of an additional
sunscreen, benzophenone-4, which were incorrectly added to
the formulation.
b) Certain lots of product may contain undeclared preservative.

The Manufacturer is Prime Enterprises, Inc., Miami Lakes, FL, not Schering-Plough Health Care Products, Cleveland, TN.

Recall of Nortrel 7/7/7 Due to Mispackaging Causes Increased Chance of Pregnancy

Barr Laboratories is voluntarily recalling three lots of its Nortrel 7/7/7 – 28 day (norethindrone and ethinyl estradiol tablets, USP) oral contraceptive due to packaging errors that could lead to an increased pregnancy risk.

The recall is effective immediately and involves Lot Numbers 290122001, 290122002, and 290122003 only.

The company has provided the following information to consumers.

Nortrel 7/7/7 – 28 day is packaged in a blister card containing four horizontal rows of seven tablets each, with each row representing one week of tablets. The first (i.e. top) row should contain yellow tablets. The second row should contain blue tablets. The third row should contain peach tablets. The fourth (i.e. bottom) row should contain white tablets. The colored tablets contain the active hormonal ingredients. The white tablets are placebos that contain no active ingredient.

Any woman who has received a Nortrel 7/7/7 – 28 day blister card with tablets in the wrong color sequence could be at an increased risk of pregnancy. In addition, changes to the menstrual cycle, including delayed bleeding, irregular bleeding or spotting, may occur.

Women taking Nortrel 7/7/7 – 28 day should carefully check their blister cards and take the following steps:

If their blister card contains out-of-sequence tablets, they should continue taking the product, immediately consult with their health care practitioner for further instructions, and return the product to their pharmacist for a replacement blister card. The company will replace any out-of-sequence blister card at no additional cost and will also cover the cost of a pregnancy test for any woman who purchased and used a blister card with out-of-sequence tablets.

If their blister card contains the correct sequence of tablets, they should continue taking the product.

Women who are not certain whether their blister card contains the correct sequence of tablets should contact the company or their pharmacist immediately, but should continue taking the product until otherwise instructed by their health care practitioner or pharmacist.

Women who believe they may have previously taken Nortrel 7/7/7 – 28 day from an out-of-sequence blister card and who are concerned about pregnancy or irregular bleeding should consult their health care practitioner for further instructions.

The Company said that out of approximately 470,000 packages of marketed Nortrel 7/7/7 – 28 day that are subject to the recall, it has received two reports in which the tablets in the blister are reversed, causing the white placebo row to be in the first row labeled “start” (i.e., week one) rather than in the last row labeled “Week 4”. Additionally, the lot number and expiration date were not visible on the back of these two cards.

Nortrel, an oral contraceptive that is a generic form of Ortho-Novum 7/7/7, is sold in pharmacies. The recalled lots were distributed between January and April 2003.

Doctors, pharmacists and consumers seeking additional information on the voluntary limited recall of Nortrel 7/7/7 – 28 day should call Barr Laboratories, Inc. Drug Information Line at 1-800-222-0910 extension 33302.
Any adverse reactions experienced with the use of this product should be reported to FDA's MedWatch program by phone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/.

WEEK ENDING JULY 26

PRODUCT a) LIPITOR Tablets (ATORVASTATIN CALCIUM) 10 mg, 90 Tablets, Rx only.
b) LIPITOR Tablets (ATORVASTATIN CALCIUM) 20 mg, 90 Tablets, Rx only.
CODE
a) Lot 12912V, Exp. 10/04; Lot 12912V 1, Exp. 10/04; Lot 12912V 2, Exp. 10/04; Lot 12912V 3, Exp. 10/04; Lot 04132V 1, Exp. 01/04; Lot 04132V 2, Exp. 01/04; Lot 04132V 3, Exp. 01/04; Lot 04132V 4, Exp. 01/04; Lot 04132V 5, Exp. 01/04; Lot 04132V 6, Exp. 01/04; Lot 04132V 7, Exp. 01/04; Lot 10772V 1, Exp. 05/04; Lot 10772U 1, Exp. 05/04; Lot 12542V 1, Exp. 05/04; Lot 2072V 1, Exp. 09/04; Lot 20722V 1, Exp. 09/04; Lot 20722V 2, Exp. 09/04; Lot 20722V 3, Exp. 09/04; Lot 20722V 4, Exp. 09/04; Lot 16942V, Exp. 09/04; Lot 16942V 1, Exp. 09/04; Lot 16942V 2, Exp. 09/04;
Lot 16942V 3, Exp. 09/04; Lot 16942V 4, Exp. 09/04; Lot 437023 1, Exp. 02/05;

b) Lot 027049D, Exp. 02/04; Lot D27048 1, Exp. 02/04; Lot D27049 1, Exp. 02/04; Lot 511022 1, Exp. 06/04; Lot 511022 2, Exp. 06/04; Lot 0511022 3, Exp. 06/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: Albers Medical Distributors, Kansas City, MO.
Manufacturer: Unknown at this time. Firm initiated recall is ongoing.
REASON Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE Approx 174,955/90-tablet bottles.
DISTRIBUTION Nationwide.

PRODUCT Amiloride Hydrochloride Tablets, USP, 5 mg, 100 tablet bottles, Rx only.
CODE Lot 035607; Expiration Date: 12/2004.
RECALLING FIRM/MANUFACTURER Par Pharmaceutical, Spring Valley, NY.
REASON Mislabeled; Bottle labeled as containing 5 mg Amiloride Hydrochloride tablets actually contains Minoxidil 2.5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE 4,821/100 count bottles.
DISTRIBUTION Nationwide.

PRODUCT Levoxyl Tablets,(Levothyroxine Sodium Tablets, USP), 112 mcg, 1000 tablet bottles, Rx only.
CODE Lot No. 7941, Exp. Date 05/2004.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN.
REASON Tablet mixup; bottles labeled to contain Levoxyl 112 mcg were found to contain Levoxyl and Soloxine 0.2 mg tablets (Vet/Animal brand-Levothyroxine).
VOLUME OF PRODUCT IN COMMERCE 2,639 bottles.
DISTRIBUTION Nationwide.

PRODUCT Premarin 0.625 mg Tablets, U.D. 100's (conjugated estrogens tablets, USP) Rx only.
CODE Lot Number IJ00170.
RECALLING FIRM/MANUFACTURER Amerisource Health Services Corp., Columbus, OH.
REASON Dissolution failure (by manufacturer Wyeth)
VOLUME OF PRODUCT IN COMMERCE 5 cartons - 100 unit dose tablets.
DISTRIBUTION Nationwide.

PRODUCT Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL 473mL (l pint) syrup, Rx only.
CODE Lot 20920.
RECALLING FIRM/MANUFACTURER Recalling Firm: Schwarz Pharma Manufacturing, Seymour, IN.
Manufacturer: Elge Inc., Rosenberg, TX. Firm initiated recall is ongoing.
REASON Mislabeled front label incorrectly states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL.
VOLUME OF PRODUCT IN COMMERCE 393 bottles.
DISTRIBUTION Nationwide.

PRODUCT EXTRA STRENGTH PAIN RELIEVER without aspirin, (Acetaminophen) 500 mg, 1000 tablet bottles, Pain Reliever/Fever Reducer.
CODE Lot # 310715.
RECALLING FIRM/MANUFACTURER Magno Humphries, Inc., Tigard, OR.
REASON Microbial contamination; product contains mold.
VOLUME OF PRODUCT IN COMMERCE 1,200 bottles.
DISTRIBUTION Nationwide.

PRODUCT Decolorized IODINE TINCTURE, (Alcohol 41-45%, Iodine 3%, Potassium Iodide 1.5%), 1 FLUID OUNCE bottle, POISON.
CODE All lot codes.
RECALLING FIRM/MANUFACTURER Denison Pharmaceuticals, Inc., Pawtucket, RI.
REASON Mislabeled; product contains undeclared ammonium hydroxide.
VOLUME OF PRODUCT IN COMMERCE 794 bottles.
DISTRIBUTION Nationwide.

PRODUCT 0.9% Sodium Chloride Injection, USP, 100 mL, ADDS Unit Single-dose container, For I.V. use, Rx only.
CODE Lot Numbers: 01-262-JT, 02-179-JT, 02-236-JT, 03-012-JT, 03-234-JT, 03-138-JT, 04-086-JT, 04-130-JT, 04-137-JT, and 05-072-JT.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL.
REASON Mislabeled; incorrect bar code on overwrap of the product.
VOLUME OF PRODUCT IN COMMERCE 980,592 bags.
DISTRIBUTION Nationwide.