FDAFDA · Food and drugs·Recall number D-0150-2018
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
Published January 10, 2018 · Recall initiated: October 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0359762106117
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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