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Class II · ModerateActive recall

Ibuprofen And Famotidine

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

Does this affect you?
Check your lot number23140190, Exp. Date 12/31/2024
Where it was soldNationwide
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 Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

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 byAlkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054 foreign manufacturer
Brand nameIBUPROFEN AND FAMOTIDINE
Generic nameIBUPROFEN AND FAMOTIDINE
Active ingredient(s)FAMOTIDINE, IBUPROFEN
Distributed by / forAscend Laboratories, LLC., Parsippany, NJ 07054
NDC67877-626-90
Show the full FDA record
Full product labelIbuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Recalling firmAscend Laboratories, LLC
DistributionNationwide
Quantity3,288 bottles
Recall initiated2023-12-29
Report date2024-01-24
Recall completed
Recall numberD-0237-2024
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

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.