Drug recall D-0150-2018
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
Reason for recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Lots and codes
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.
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 183437 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 20, 2017
- Terminated
- June 2, 2020
Related products
- Diphenoxylate Hydrochloride and Atropine Sulfate – drug information
- NDC 59762-1061 Diphenoxylate Hydrochloride and Atropine Sulfate · Diphenoxylate Hydrochloride 2.5 mg/1; Atropine Sulfate .025… · Mylan Pharmaceuticals Inc.