Recalling firm
Hikma Pharmaceuticals USA Inc.
Product type
Drug
Status
Ongoing
Report date
2024-03-27
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
22,644 ampuls
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Product description
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Code / lot info
Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →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.