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.
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
Lot numbers, UPCs & expiration codes
Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0392-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 12, 2024
- FDA report date
- Mar 27, 2024
- Quantity
- 22,644 ampuls
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0392-2024, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94208
- Address
- 2 Esterbrook Ln
- Code information
- Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
- Postal code
- 08003-4002
- Report date
- Mar 27, 2024
- Product type
- Drugs
- Recall number
- D-0392-2024
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2024