Recalls / Class II
Class IID-0719-2021
Product
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
- 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
- Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Why it was recalled
Presence of Foreign Substance- Potential of metal contamination.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 3800 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-07-07
- FDA classified
- 2021-08-10
- Posted by FDA
- 2021-08-18
- Terminated
- 2023-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0719-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.