Sulfamethoxazole And Trimethoprim Tablet
FDA Recall NDC 53489-145
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 Sulfamethoxazole And Trimethoprim (NDC 53489-145). A significant event, classified as Class II, was initiated on Apr 19, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "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."
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 II Terminated
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.
Apr 19, 2018
May 23, 2018
1,908 500-count bottles
Recall Profile & Regulatory Data
Event ID
79909
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 28, 2019
Product Description
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
53489-145-01Product
53489-145-05Product
53489-146-01Product
53489-146-05Product
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.
