Drug product
NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
D-0399-2021
Product summary
- Event
- Event 87843
- Status
- Terminated
- Classification
- Class I
- Quantity
- a) 69,289 bottles; b) 9,076 bottles
- Official record key
drug-enforcement:D-0399-2021
Official wording
Reason: Subpotent Drug
Code information: Lot #: a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A, M328J19-7A, Exp. 08/31/2021, M328K19-2, M328K19-4A, Exp. 09/30/2021; b) M328J19-9B Exp. 08/31/2021
Distribution pattern: Nationwide within the United States including Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent