April 2018 FDA Recall Sulfamethoxazole And Trimethoprim by Sun Pharmaceutical Industries, Inc.
D-0802-2018 - Presence of Foreign Substance

This Class II drug recall was initiated by Sun Pharmaceutical Industries, Inc. on April 19, 2018 for the product Sulfamethoxazole And Trimethoprim. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0802-2018

Reason for Recall
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Initiated
04-19-2018
Reported
05-23-2018
Quantity
1,908 500-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79909
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.
Sun Pharmaceutical Industries, Inc.
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2019
Product Description About Product Description
Full technical description of the product.
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

Batch or Lot Expiration Information

Lot# Lot 6848501, EXP 04/2020

Affected Packages Involved in this Recall

53489-145-01 Sulfamethoxazole And Trimethoprim
53489-145-05 Sulfamethoxazole And Trimethoprim
53489-146-01 Sulfamethoxazole And Trimethoprim
53489-146-05 Sulfamethoxazole And Trimethoprim