Drug product
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
D-0397-2025
Product summary
- Event
- Event 96666
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,984 Bottles
- Official record key
drug-enforcement:D-0397-2025
Official wording
Reason: Subpotent
Code information: Lot # D2400725, Exp Date: 03/2026
Distribution pattern: Nationwide US.
Derived failure modes
-
Potency or specification failure
Subpotent