RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II ___________________________________ PRODUCT a) Thyro-Tab 0.025mg, 150,000-tablet bulk drums intended for repackaging, Rx only, Recall # D-220-2008; b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, 100- and 1,000-tablet bottles, RX only; NDC 0456-1320-01 (100-ct.) and NDC 0456-1320-00 (1,000-ct.), Recall # D-221-2008 CODE a) Lot HA08207, Exp. April 2008; Lot HC13007, Exp. May 2008; b) Lot 050701 (100-tab.) and 050702 (1,000-tab), both from bulk lot HA08207, Exp. April 2008; Lot 060736 (100-tab.) and 070706 (1,000-tab), both from bulk lot HC13007, Exp. May 2008 RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah, IA, by letters dated April 14. 2007 and April 23, 2008. Firm initiated recall is ongoing. REASON Subpotent; (8-month and 9-month stability intervals) VOLUME OF PRODUCT IN COMMERCE 3,820,252 bulk Thyro-Tab tablets; 17,681/100-tab. bottles and 632/1,000-tab. bottles Levothroid DISTRIBUTION Nationwide ___________________________________ PRODUCT Paroxetine Tablets, USP, 20 mg, 100 count bottles, NDC Number: 68382-098-01, Recall # D-222-2008 CODE Lot MG3179, Exp date 5/2009 RECALLING FIRM/MANUFACTURER Recalling Firm: Zydus Pharmaceuticals USA Inc., Princeton, NJ, by letters on April 22, 2008. Manufacturer: Cadila Healthcare Ltd., Ahmedabad, India. Firm initiated recall is ongoing. REASON Mislabeled; bottle labeled as containing Paroxetine 20 mg Tablets actually contain Warfarin 4mg Tablets VOLUME OF PRODUCT IN COMMERCE 14,256 bottles DISTRIBUTION Nationwide ___________________________________ PRODUCT Multiret Folic 500 Tablets, ferrous sulfate, 525 mg, 6 x 10 film coated tablets, Rx only, --- Also labeled as Multiret Folic 500 Tablets, Amide Pharmaceutical ---- NDC 52152-048-14 and Multi-Ferrous Folic 500 Tablets, NDC 0677-0990-06, Recall # D-223-2008 CODE NDC 0677-0990-06; Lot 06358A1; Exp. date: Apr.08; NDC 52152-048-14: Lot numbers: 60358A2, Exp. date: Apr. 08; Lot 60358A3, Exp. date Apr 08; Lot 60358A4, Exp. Apr 08; Lot 60633A1, Exp. Jul 08; Lot 60633A2, Exp. Jul 08; Lot 60823A1, Exp. Sep 08; Lot 60823A2, Exp. Jul 08; Lot 60823A3, Exp. Spe 08; Lot 70065A1, Exp. Jan 09; Lot 70065A2, Exp. Jan 09; Lot Numbers 70254A1, Exp Mar 09; Lot 70254A2, Exp. Mar 09; Lot 70607A1, Exp Jul. 09; Lot 70819A1, Exp Nov. 09 60358A1 Apr-08 60358A2 Apr-08 60358A3 Apr-08 60358A4 Apr-08 60633A1 Jul-08 60633A2 Jul-08 60823A1 Sep-08 60823A2 Sep-08 60823A3 Sep-08 70065A1 Jan-09 70065A2 Jan-09 70254A1 Mar-09 70254A2 Mar-09 70607A1 Jul-09 70819A1 Nov-09 RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing. REASON Subpotent; Folic Acid VOLUME OF PRODUCT IN COMMERCE 15 lots; 169,433 bottles DISTRIBUTION Nationwide RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III ___________________________________ PRODUCT PREMPRO? (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, one carton contains 3 EZ-DIAL? Dispensers of 28 tablets each. One EZ-DIAL? Dispenser (NDC 0046-0938-08) contains 28 cream PREMPRO? Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN? & 1.5 mg of medroxyprogesterone acetate; NDC 0046-0938-09, Recall # D-218-2008 CODE Lot: B88216, Exp. 09/08 RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters dated April 2, 2008. Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failed USP Dissolution Specifications VOLUME OF PRODUCT IN COMMERCE 23,832 cartons of 3 Dispensers DISTRIBUTION Nationwide ___________________________________ PRODUCT Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100 tablet bottles, NDC 67253-263-10 and 1000 tablet bottles, NDC 67253-263-11, Rx only, Recall # D-233-2008 CODE Lot Number 61895A (100's); Lot Number 61895B (1000's) RECALLING FIRM/MANUFACTURER Recalling Firm: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, by letters on May 2, 2008. Manufacturer: West-Ward Pharmaceutical Corp., Eatontown, NJ. Firm initiated recall is ongoing. REASON Exceeded Impurity Specification; 24 month stability. VOLUME OF PRODUCT IN COMMERCE 3580 bottles of 100, 592 bottles of 1000 DISTRIBUTION Nationwide