Why it was recalled
Labeling: Wrong Barcode
Product description
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Lot numbers, UPCs & expiration codes
Lot #: CH0324001, Exp. Date 3/4/2025
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-0480-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Apr 30, 2024
- FDA report date
- May 8, 2024
- Quantity
- 1,895 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Injectables USA Inc
Original FDA data
Every field from FDA enforcement report D-0480-2024, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 94528
- Address
- 36 Stults Rd
- Code information
- Lot #: CH0324001, Exp. Date 3/4/2025
- Postal code
- 08810-1540
- Report date
- May 8, 2024
- Product type
- Drugs
- Recall number
- D-0480-2024
- Classification
- Class III
- Recalling firm
- Hikma Injectables USA Inc
- Product quantity
- 1,895 bags
- Reason for recall
- Labeling: Wrong Barcode
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 30, 2024
- Initial firm notification
- Letter
- Center classification date
- May 2, 2024