FDA Recall D-0392-2024

Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ

Class II Ongoing 793 days on record

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

Product

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

Lot / code: Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024

Quantity: 22,644 ampuls

Reason for recall

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Recall record

Recall number: D-0392-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2024-03-12
Classified by FDA Center: 2024-03-21
FDA published: 2024-03-27
Recalling firm: Hikma Pharmaceuticals USA Inc.
Firm location: Cherry Hill, NJ

Drug identification

Brand name(s): INFUMORPH 200
Generic name(s): MORPHINE SULFATE
Manufacturer(s): Hikma Pharmaceuticals USA Inc.
NDC(s): 0641-6039, 0641-6040
Route(s): EPIDURAL, INTRATHECAL

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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