FDA recall D-0035-2021

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.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-09-17

Report date

2020-10-28

Termination date

2022-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2021