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SafetyAlerts
July 11, 2002

King Pharmaceuticals Has Recalled Levoxyl Tablets

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 50 mcg (0.05 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels Pharmaceuticals, St. Petersburg, FL. Recall # D-345-2.

Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 75 mcg (0.075 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-346-2;

Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 88 mcg (0.088 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-347-2;

Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 100 mcg (0.1 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-348-2.
CODE
50 mcg, 100 tablet bottle: Lot Nos. 6533, 6534, 6567, 6568, 6569, 6570 (exp 05/02); 6571 (Exp 06/02); 6623, 6624, 6626, 6627, 6628 (Exp 07/02); 6648, 6649, 6651, 6652, 6658, 6660 (Exp 08/02); 6732, 6736, 6737, 6738, 6740 (Exp. 10/02); 6771, 6772, 6795, 6796, 6797 (Exp 11/02); 50 mcg, 1000 tablet bottle: Lot Nos. 6572, 6573 (Exp 06/02); 6650, 6659, 6661, 6662 (Exp 08/02); 6733, 6735, (Exp 10/02); 6773 (Exp 11/02); 75 mcg, 100 tablet bottle: Lot Nos. 6542, 6543, 6574, 6576 (Exp 06/02); 6633 (Exp 07/02); 6634, 6635, 6636, 6637 (Exp 08/02); 6694, 6695, 6696, 6698, 6699, 6701, 6702, 6703, (Exp 09/02); 6753, 6754, 6755, 6756 (Exp 10/02);75 mcg, 1000 tablet bottle: Lot Nos. 6578 (Exp 07/02); 6638 (Exp 08/02); 6697, 6700 (Exp 09/02); 6807 (Exp 11/02);88 mcg, 100 tablet bottle: Lot Nos. 6538, 6539, (Exp 05/02); 6593 (Exp 06/02); 6646 (Exp 07/02); 6668, 6669, 6670 (Exp 08/02); 6769, 6770, 6802, 6803 (Exp 11/02);88 mcg, 1000 tablet bottle: Lot Nos. 6538 (Exp 05/02); 6668 (Exp 08/02); 6802 (Exp 11/02) 100 mcg, 100 tablet bottle: Lot Nos. 6555, 6556, 6557, 6562, 6563, 6564 (Exp 05/02); 6603, 6604, 6605, 6606 (Exp 06/02); 6645, 6716, 6718, 6722 (Exp 09/02); 6726, 6727, 6728, 6729 (Exp 10/02); 6764 (Exp 11/02);100 mcg, 1000 tablet bottle: Lot Nos. 6613, 6614, 6615, 6616, 6617, 6618, 6631, 6632 (Exp 07/02); 6642, 6643, 6644, 6717, 6719, 6723 (Exp 09/02); 6724, 6725, 6761, 6762 (Exp 10/02); 6763
(Exp 11/02).

RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on May 10, 2002.
Manufacturer: King Pharmaceuticals, Inc., St. Petersburg, FL.
Firm initiated recall is ongoing.

REASON
Lack of assurance product will maintain potency throughout its labeled expiration date.

VOLUME OF PRODUCT IN COMMERCE
2,885,015 units.

DISTRIBUTION
Nationwide and Internationally.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.