Drug 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
D-0237-2024
Product summary
- Event
- Event 93701
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,288 bottles
- Official record key
drug-enforcement:D-0237-2024
Official wording
Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Code information: 23140190, Exp. Date 12/31/2024
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet