D-0150-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2018
- Initiation Date
- October 20, 2017
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183437 bottles
Product Description
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
Distribution Pattern
Nationwide in the USA
Code Information
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.