FDA Recall D-1298-2020

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 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.

Lot / code: Lots: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-2020.

Quantity: 112,140 bottles

Reason for recall

Superpotent Drug.

Recall record

Recall number: D-1298-2020
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

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