FDA Recall D-0395-2021

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 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Lot / code: Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 Exp. 03/31/2022

Quantity: a) 66,155 bottles; b) 26,212 bottles

Reason for recall

Subpotent Drug

Recall record

Recall number: D-0395-2021
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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