Pfizer Inc. recalls diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1),…

Recall date

October 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0150-2018

FDA classification

Class I

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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