Recalls / Class II
Class IID-1535-2020
Product
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.
- Brand name
- Sulfamethoxazole And Trimethoprim
- Generic name
- Sulfamethoxazole And Trimethoprim
- Active ingredients
- Sulfamethoxazole, Trimethoprim
- Route
- Oral
- NDCs
- 65862-419, 65862-420
- FDA application
- ANDA090624
- Affected lot / code info
- Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Why it was recalled
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 5748 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-08-10
- FDA classified
- 2020-08-21
- Posted by FDA
- 2020-09-02
- Terminated
- 2024-06-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1535-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.