Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: A...
FDA Recall #D-0237-2024 — Class II — December 29, 2023
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.
Recalling Firm
Ascend Laboratories, LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,288 bottles
Distribution
Nationwide
Code Information
23140190, Exp. Date 12/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated