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).
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.
Lot numbers, UPCs & expiration codes
Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1535-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 5748 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1535-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86190
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
- Postal code
- 08520-1401
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1535-2020
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 5748 bottles
- Termination date
- Jun 28, 2024
- Reason for recall
- Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Aug 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2020