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
FDA recall notice · announced October 28, 2020 · Acella Pharmaceuticals
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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
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.
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: M327E19-1 Exp. 10/2020
Quantity: 19,296 bottles
Status: Terminated
Products in this recall event:
- NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01 (D-0036-2021)
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.