October 2015 FDA Recall Drug by Mutual Pharmaceutical Company, Inc.
D-0572-2016 - Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

This Class II drug recall was voluntarily initiated by Mutual Pharmaceutical Company, Inc. on October 9, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign substance -this recall has been intiated due to the presence of a polyethylene piece on the finished product.. The product was distributed in MS and the recall is currently terminated.

Recall Number: D-0572-2016

Reason for Recall
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Initiated
10-09-2015
Reported
01-27-2016
Quantity
9526

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72382
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mutual Pharmaceutical Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

Batch or Lot Expiration Information

Lot# 6727001 Exp 01/18