Drug product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
D-0396-2025
Product summary
- Event
- Event 96666
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,885 Bottles
- Official record key
drug-enforcement:D-0396-2025
Official wording
Reason: Subpotent
Code information: Lot # D2300044, Exp Date: 12/2025
Distribution pattern: Nationwide US.
Derived failure modes
-
Potency or specification failure
Subpotent