Recalling firm
Ascend Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2024-01-24
Distribution
Nationwide
Firm state
NJ
Product quantity
3,288 bottles
Initiated by
Voluntary: Firm initiated
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.
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
Code / lot info
23140190, Exp. Date 12/31/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.