Status
Ongoing
Drug Enforcement 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.
Classification
Class II
Report Date
March 27, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 22,644 ampuls
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Address
-
2 Esterbrook Ln
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0392-2024
- Event ID
- 94208
- Recall initiation date
- March 12, 2024
- Center classification date
- March 21, 2024
- Code info
- Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
- More code info
- —