FDA Recall D-0150-2018

Pfizer Inc. · New York, NY

Class I — life-threatening Terminated 956 days on record

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

Product

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977

Lot / code: Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.

Quantity: 183437 bottles

Reason for recall

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Recall record

Recall number: D-0150-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2017-10-20
Classified by FDA Center: 2018-01-04
FDA published: 2018-01-10
Terminated: 2020-06-02
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Generic name(s): DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Manufacturer(s): Mylan Pharmaceuticals Inc.
NDC(s): 59762-1061
Route(s): ORAL

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