
SafetyAlerts
July 11, 2002King 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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