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Recall Observatory FDA recall evidence

Drug product

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

D-0392-2024

March 12, 2024

Class II

Product summary

Firm
Hikma Pharmaceuticals USA Inc.
Event
Event 94208
Status
Ongoing
Classification
Class II
Quantity
22,644 ampuls
Official record key
drug-enforcement:D-0392-2024

Official wording

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

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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