Drug product
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
D-0035-2021
Product summary
- Event
- Event 86467
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19,296 bottles
- Official record key
drug-enforcement:D-0035-2021
Official wording
Reason: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Code information: Lot #: M327E19-1 Exp. 10/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent