Drug product
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
D-0470-2025
Product summary
- Event
- Event 96979
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,344- 1000 count bottles
- Official record key
drug-enforcement:D-0470-2025
Official wording
Reason: Presence of a foreign substance: black hair found embedded in tablet.
Code information: Lot #: MLF2401A, Exp 01/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign substance