FDA Recall D-0035-2021
Acella Pharmaceuticals, LLC · Alpharetta, GA
Class I — life-threatening Terminated 812 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0035-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2020-09-17
- Classified by FDA Center
- 2020-10-19
- FDA published
- 2020-10-28
- Terminated
- 2022-12-08
- Recalling firm
- Acella Pharmaceuticals, LLC
- Firm location
- Alpharetta, GA
Drug identification
- Brand name(s)
- NP THYROID 15
- Generic name(s)
- LEVOTHYROXINE, LIOTHYRONINE
- Manufacturer(s)
- Acella Pharmaceuticals, LLC
- NDC(s)
42192-327, 42192-329, 42192-330, 42192-331, 42192-328- Route(s)
- ORAL