FDA Recall D-1299-2020
Acella Pharmaceuticals, LLC · Alpharetta, GA
Class I — life-threatening Terminated 607 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.
Reason for recall
Superpotent Drug.
Recall record
- Recall number
D-1299-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the US and Puerto Rico
- Recall initiated
- 2020-05-22
- Classified by FDA Center
- 2020-06-08
- FDA published
- 2020-06-10
- Terminated
- 2022-01-19
- 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