Recalls / Class II
Class IID-0392-2024
Product
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
- Brand name
- Infumorph 200
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Epidural, Intrathecal
- NDCs
- 0641-6039, 0641-6040
- FDA application
- NDA018565
- Affected lot / code info
- Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Why it was recalled
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 22,644 ampuls
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-03-12
- FDA classified
- 2024-03-21
- Posted by FDA
- 2024-03-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0392-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.