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Class II · ModerateRecall completed

Sulfamethoxazole And Trimethoprim

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic nameSULFAMETHOXAZOLE AND TRIMETHOPRIM
Active ingredient(s)SULFAMETHOXAZOLE, TRIMETHOPRIM
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC65862-420-05
Show the full FDA record
Full product labelSulfamethoxazole 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.
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the U.S.
Quantity5748 bottles
Recall initiated2020-08-10
Report date2020-09-02
Recall completed2024-06-28
Recall numberD-1535-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.