Levoxyl Recall. . . .again. . . .

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U.S. FOOD AND DRUG ADMINISTRATION - JULY 29, 2004http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.htmlREASONStability, inability to maintain stability through labeled expiration.VOLUME OF PRODUCT IN COMMERCE992,428 bottles.DISTRIBUTIONNationwide and Puerto Rico.25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs and 200 mcgs pillsPRODUCTa) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 25mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5025-1 and NDC 52604-5025-2. Recall # D-216-4; Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),50mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5050-1 and NDC 52604-5050-2. Recall # D-217-4;c) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 100mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5100-1 and NDC 52604-5100-2. Recall # D-218-4; d) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 125mcg, 100 count bottles, Rx only, NDC 52604-5125-1. Recall # D-219;e) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),137mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5137-1 and NDC 52604-5137-2. Recall # D-220-4;f) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 150mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5150-1 and NDC 52604-5150-2. Recall #- D-221-4;g) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 175mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5175-1 and NDC 52604-5175-2. Recall # D-222-4;h) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 200mcg, 100 and 1000 count bottles, Rx only, NDC 52604-5200-1 and NDC 52604-5200-2. Recall # D-223-4.CODEa) 100 count: Lot No. 8210, expiration 09/04 ---- 1000 count: Lot No. 8211,

expiration 09/04; 100 count - Lot No. 8122, Exp Date 07/04; Lot No. 8125, Exp Date 07/04; Lot No. 8127, Exp Date 07/04; Lot No. 8129, Exp Date 07/04, Lot No. 8132, Exp Date 07/04, Lot No. 8131, Exp Date 07/04 ----- 1000 count - Lot No.- Expiration: Lot No. 8124, Exp Date 07/04; Lot No. 8126, Exp Date 07/04; Lot No. 8128, Exp Date 07/04; Lot No. 8130, Exp Date 07/04;c) 100 count - Lot No. 8079, Exp Date 07/04, Lot No. 8136, Exp Date 07/04 ---- 1000 count - Lot No. 8137, Exp Date 07/04; Lot No. 8138, Exp Date 07/04; Lot No. 8111, Exp Date 07/04;d) Lot No. 8087, Expiration 07/04;e) 100 count - Lot No. 8105, Exp 07/04; Lot No. 8107, Exp 07/04 ---- 1000 count - Lot No. 8104, Exp 07/04; Lot No. 8106, Exp 07/04;f) 100 count - Lot No. 8264, Exp 09/04; Lot No. 8266, Exp 09/04; Lot No. 8268, Exp 10/04; Lot No. 8270, Exp 10/04; Lot No. 8377, Exp 12/04, Lot No. 8090, Exp 07/04; Lot No. 8092, Exp

07/04; Lot No. 8094, Exp 07/04; Lot No. 8155, Exp 08/04; Lot No. 8156, Exp 08/04, Lot No. 8157, Exp 08/04; Lot No. 8158, Exp 07/04, Lot No. 8159, Exp 07/04 ---- 1000 count - Lot No. 8265, Exp 09/04; Lot No. 8267, Exp 09/04; Lot No. 8269, Exp 10/04; Lot No. 8376, Exp 12/04; Lot. No. 8263 , Exp 09/04, Lot No. 8089, Exp 07/04; Lot No. 8091, Exp 07/04; Lot No. 8093, Exp 07/04;g) 100 count - Lot No. 8121, Exp 10/04; Lot No. 8297, Exp 10/04; Lot No. 8115, Exp 07/04; Lot No. 8116, Exp 07/04; Lot No. 8117, Exp 07/04; Lot No. 8118, Exp 07/04 ----- 1000 count - Lot No. 8119, Exp 10/04; Lot No. 8120, Exp 10/04;h) 100 count - Lot No. 8256, Exp 09/04; Lot No.8258, Exp 09/04; Lot No. 8260, Exp 09/04; Lot No. 8096, Exp 07/04; Lot No. 8098, Exp 07/04; Lot No. 8100, Exp 07/04; Lot No. 8101, Exp 07/04 -----1000 count - Lot No. 8255, Exp 09/04; Lot No. 8257, Exp 09/04; Lot No. 8259, Exp 09/04; Lot No. 8095, Exp

07/04; Lot No. 8097, Exp 07/04; Lot No. 8099, Exp 07/04.RECALLING FIRM/MANUFACTURERKing Pharmaceuticals, Inc., Bristol, TN, by letter on June 22, 2004. Firm initiated recall is ongoing.REASONStability, inability to maintain stability through labeled expiration.VOLUME OF PRODUCT IN COMMERCE992,428 bottles.DISTRIBUTIONNationwide and Puerto Rico.__________________________________________________