← FDA ENFORCEMENT
D-0392-2024Class II

Hikma Pharmaceuticals USA Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & Qualification
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.

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

Data: U.S. FDA. 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. Open the enforcement explorer →