March 2024 FDA Recall Infumorph 200 by Hikma Pharmaceuticals Usa Inc.
D-0392-2024 - The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on March 12, 2024 for the product Infumorph 200. The FDA reported the reason for recall as the filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0392-2024
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
03-12-2024
03-27-2024
22,644 ampuls
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Batch or Lot Expiration Information
Lot# : 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
