Recalls / Class II
Class IID-0237-2024
Product
Ibuprofen 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
- Brand name
- Ibuprofen And Famotidine
- Generic name
- Ibuprofen And Famotidine
- Active ingredients
- Famotidine, Ibuprofen
- Route
- Oral
- NDC
- 67877-626
- FDA application
- ANDA211890
- Affected lot / code info
- 23140190, Exp. Date 12/31/2024
Why it was recalled
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 3,288 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-12-29
- FDA classified
- 2024-01-17
- Posted by FDA
- 2024-01-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.