FDA-Drug2024-05-08Class III
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
Hikma Injectables USA Inc
Hazard
Labeling: Wrong Barcode
Sold states
Nationwide within the United States
Affected count
1,895 bags
Manufactured in
36 Stults Rd, Dayton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0480-2024Don't want to check this manually?
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