Drug product
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
D-0353-2023
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 91654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,276 bottles
- Official record key
drug-enforcement:D-0353-2023
Official wording
Reason: Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Code information: Lot # HE02221, Exp. 05/2023
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification