JUNE 2006

WEEK ENDING JUNE 3

PRODUCT Verelan® PM extended-release capsules (verapamil hydrochloride), 300 mg, 100 capsules per bottle, Rx only, NDC 0091-4087-01, 
CODE Lots: 5K066 (exp. 7/07), 5K124 (exp. 8/07)
RECALLING FIRM/MANUFACTURER Elan Holdings, Inc., Gainesville, GA
REASON Low fill weight capsules.
VOLUME OF PRODUCT IN COMMERCE 10,269/100-capsule bottles
DISTRIBUTION Nationwide

PRODUCT Pulmicort Respules 0.25 mg/2mL (budesonide inhalation suspension) Rx only, NDC 0186-1988-04, 
CODE Lot Number: MA0133 Exp. Date: JAN 08
RECALLING FIRM/MANUFACTURER AstraZeneca LP, Westborough, MA
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 384 units
DISTRIBUTION Nationwide

PRODUCT Greenstone brand cabergoline tablets, 0.5 mg, 8 tablets per bottle, RX only, NDC 59762-0100-1, 
CODE Lot B922A (exp. 3/07), NDC 59762-0100-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greenstone Ltd., Peapack, NJ,
Manufacturer: Pfizer Italia S.r.l. Marino del Tronto, Italy. 
REASON Product will not meet established potency and impurity specifications throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE 54,270/8 tablet bottles
DISTRIBUTION Nationwide and PR

PRODUCT Dostinex tablets (cabergoline), 0.5 mg, 8 tablets per bottle, Rx only, NDC 0013-7001-12, 
CODE Lots: A526A (exp. 2/07), A528A (exp. 2/07), B086A (exp. 5/07), B599Y (exp. 1/07), B921Z (exp. 3/07), 4HXG7B (exp. 10/06), 4HXGAK (exp. 11/06), 4HXG6E (exp. 10/06), 4HXG6F (exp. 10/06); NDC 0013-7001-12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., NY, NY, 
Manufacturer: Pfizer Italia S.r.l., Marino, Italy. 
REASON Product will not meet established potency and impurity specifications throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE 404,969/8-tablet bottles
DISTRIBUTION Nationwide and PR

PRODUCT
a) PREMPRO™ (conjugated estrogen/medroxyprogesterone acetate tablets) 0.45
mg/1.5 mg, Rx only, NDC 0046-0937-08. 
b) PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3
mg/1.5 mg, Rx only, NDC 0046-0938-08. 
CODE
a) Lot A66957 (exp. 8/06);
b) Lot B13132 (exp. 2/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, 
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY, 
REASON FAILED USP DISSOLUTION TEST REQUIREMENT.
VOLUME OF PRODUCT IN COMMERCE
Prempro 0.45 mg/1.5 mg: 25,186 cartons of 3 dispensers;
Prempro 0.3 mg/1.5 mg: 23,254 cartons of 3 dispensers
DISTRIBUTION Nationwide

 WEEK ENDING JUNE 10

PRODUCT Retavase Half-Kit (Reteplase recombinant) with 1 single-use vial Retavase powder (10 unit vial; 10.4 U strength), Rx only, NDC 67286-040-02
CODE Lot numbers: 767174E (exp. 12/06), 767174F (exp. 12/06), 767486B (exp. 3/07), 767486D (exp. 3/07);
RECALLING FIRM/MANUFACTURER
Recalling Firm/Manufacturer: Pdl Biopharma, Freemont, CA
Packager/Labeler: Cardinal Health Packaging Services, Philadelphia, PA.
REASON Kit may contain unlabeled vial of drug product.
VOLUME OF PRODUCT IN COMMERCE 5,908 half-kits
DISTRIBUTION Nationwide

WEEK ENDING JUNE 17

PRODUCT Acetaminophen 500 mg Tablets, OTC, distributed in bottles of 100 tablets and 1000 tablets or in bulk form. (1) NDC 0677-1784-10 --- URL brand ACETAMINOPHEN TABLETS, USP --- 500 mg --- EXTRA STRENGTH --- 1000 TABLETS --- (2) NDC 0904-1988-80 --- MAJOR brand EXTRA STRENGTH Mapap TABLETS --- 1000 ACETAMINOPHEN TABLETS --- 500 MG. EACH --- (3) NDC 62107-050-01 --- HealthSen$e brand TACTINAL Tablets --- Extra Strength - 500mg --- Acetaminophen --- 500 mg each --- 100 Tablets. The product was also sold to 1 account as bulk tablets, 
CODE Lot 03M847 (exp. 12/06)
RECALLING FIRM/MANUFACTURER PDK Labs, Inc., Hauppauge, NY,
REASON Firm received a complaint of spotted (discolored) tablets due to mold contamination.
VOLUME OF PRODUCT IN COMMERCE 4.5 Million tablets
DISTRIBUTION Nationwide