D-0392-2024 Class II Ongoing
FDA drug recall D-0392-2024 was initiated by Hikma Pharmaceuticals USA Inc. on March 12, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 22,644 ampuls.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2024
- Initiation Date
- March 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,644 ampuls
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
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024