Drug 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
D-0150-2018
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 78332
- Status
- Terminated
- Classification
- Class I
- Quantity
- 183437 bottles
- Official record key
drug-enforcement:D-0150-2018
Official wording
Reason: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
SUPERPOTENT