The Food and Drug Administration (FDA) released the following information:
PRODUCT
a) 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;
b) 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.
CODE
a) 100 count: Lot No. 8210, expiration 09/04 ----
1000 count: Lot No. 8211, expiration 09/04;
b) 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/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letter on June 22, 2004. Firm initiated recall is ongoing.
REASON
Stability, inability to maintain stability through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE
992,428 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
