Drug product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
D-0006-2026
Product summary
- Event
- Event 97613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54,432 bottles
- Official record key
drug-enforcement:D-0006-2026
Official wording
Reason: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Code information: Lot # D2300045, Exp 12/31/2025.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Subpotent