Sulfamethoxazole And Trimethoprim Tablet
FDA Recall NDC 53746-271
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 53746-271). A significant event, classified as Class II, was initiated on Sep 27, 2011 by Amneal Pharmaceuticals Of New York Llc. The reported reason for this action was: "Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg"
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
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Sep 27, 2011
Jul 30, 2014
284/800 mg tablets
Recall Profile & Regulatory Data
Event ID
64611
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Shamrock Medical Solutions Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to the following states: CO, MA, OH, TX & WY.
Termination Date
Jul 31, 2014
Product Description
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
Batch or Lot Expiration Information
Lot# Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01
Affected Packages Involved in this Recall
53746-271-50Product
53746-271-01Product
53746-271-05Product
53746-271-10Product
53746-272-11Product
53746-272-24Product
53746-272-01Product
53746-272-02Product
53746-272-05Product
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.
