FDA 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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-20

Report date

2018-01-10

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0150-2018