PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: January 10, 2018 Initiated: October 20, 2017 #D-0150-2018

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

Details

Recalling Firm
Pfizer Inc.
Units Affected
183437 bottles
Distribution
Nationwide in the USA
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 183437 bottles.
Why was this product recalled?
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Which agency issued this recall?
This recall was issued by the FDA Drug on January 10, 2018. Severity: Critical. Recall number: D-0150-2018.