FDA Recall D-0237-2024

Ascend Laboratories, LLC · Parsippany, NJ

Class II Ongoing 867 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 23140190, Exp. Date 12/31/2024

Quantity: 3,288 bottles

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.

Recall record

Recall number: D-0237-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2023-12-29
Classified by FDA Center: 2024-01-17
FDA published: 2024-01-24
Recalling firm: Ascend Laboratories, LLC
Firm location: Parsippany, NJ

Drug identification

Brand name(s): IBUPROFEN AND FAMOTIDINE
Generic name(s): IBUPROFEN AND FAMOTIDINE
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-626
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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