Diphenoxylate Hydrochloride And Atropine Sulfate Tablet
FDA Recall NDC 59762-1061
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diphenoxylate Hydrochloride And Atropine Sulfate (NDC 59762-1061). A significant event, classified as Class I, was initiated on Oct 20, 2017 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Oct 20, 2017
Jan 10, 2018
183437 bottles
Recall Profile & Regulatory Data
Event ID
78332
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 02, 2020
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
59762-1061-1Product
59762-1061-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
