Sulfamethoxazole And Trimethoprim Tablet
FDA Recall NDC 65862-419
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sulfamethoxazole And Trimethoprim (NDC 65862-419). A significant event, classified as Class II, was initiated on Jul 07, 2021 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of Foreign Substance- Potential of metal contamination."
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
July 2021 Class II Recall: Presence of Foreign Substance- Potential of metal contamination.
Recall Number
Class II Terminated
Presence of Foreign Substance- Potential of metal contamination.
Jul 07, 2021
Aug 18, 2021
3800 bottles
Recall Profile & Regulatory Data
Event ID
88227
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 18, 2023
Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Batch or Lot Expiration Information
Batch# Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Affected Packages Involved in this Recall
65862-419-20Product
65862-419-01Product
65862-419-05Product
65862-419-99Product
65862-420-20Product
65862-420-01Product
65862-420-05Product
65862-420-99Product
Class II Terminated
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Aug 10, 2020
Sep 02, 2020
5748 bottles
Recall Profile & Regulatory Data
Event ID
86190
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jun 28, 2024
Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
Batch or Lot Expiration Information
Lot# s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Affected Packages Involved in this Recall
65862-419-20Product
65862-419-01Product
65862-419-05Product
65862-419-99Product
65862-420-20Product
65862-420-01Product
65862-420-05Product
65862-420-99Product
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.
