D-0035-2021 Class I Terminated

Recalled by Acella Pharmaceuticals, LLC — Alpharetta, GA

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