Drug product
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
D-0518-2025
Product summary
- Event
- Event 97103
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 82,159 bottles
- Official record key
drug-enforcement:D-0518-2025
Official wording
Reason: Subpotent Drug: Assay below the approved specification
Code information: Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent