FDA Recall D-0399-2021

Acella Pharmaceuticals, LLC · Alpharetta, GA

Class I — life-threatening Terminated 1049 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Lot / code: Lot #: a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A, M328J19-7A, Exp. 08/31/2021, M328K19-2, M328K19-4A, Exp. 09/30/2021; b) M328J19-9B Exp. 08/31/2021

Quantity: a) 69,289 bottles; b) 9,076 bottles

Reason for recall

Subpotent Drug

Recall record

Recall number: D-0399-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide within the United States including Puerto Rico
Recall initiated: 2021-04-29
Classified by FDA Center: 2021-05-24
FDA published: 2021-06-02
Terminated: 2024-03-13
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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