Drug product
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
D-0480-2024
Product summary
- Event
- Event 94528
- Status
- Completed
- Classification
- Class III
- Quantity
- 1,895 bags
- Official record key
drug-enforcement:D-0480-2024
Official wording
Reason: Labeling: Wrong Barcode
Code information: Lot #: CH0324001, Exp. Date 3/4/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Wrong