D-0035-2021 Class I Terminated
FDA drug recall D-0035-2021 was initiated by Acella Pharmaceuticals, LLC on September 17, 2020 and is designated Class I. Reason for recall: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. The recall status is terminated (terminated December 8, 2022). Affected quantity: 19,296 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 28, 2020
- Initiation Date
- September 17, 2020
- Termination Date
- December 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,296 bottles
Product Description
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
Reason for Recall
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: M327E19-1 Exp. 10/2020