D-0237-2024 Class II Ongoing
FDA drug recall D-0237-2024 was initiated by Ascend Laboratories, LLC on December 29, 2023 and is designated Class II. Reason for recall: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine. The recall status is ongoing. Affected quantity: 3,288 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2024
- Initiation Date
- December 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,288 bottles
Product Description
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
Reason for Recall
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Distribution Pattern
Nationwide
Code Information
23140190, Exp. Date 12/31/2024