Hikma Injectables USA Inc Provisional
FDA Flags (4)
Class II RecallJan 2025
Hikma Injectables USA Inc
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc
Classification: Class II
Class II RecallJan 2025
Hikma Injectables USA Inc
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Ro
Classification: Class II
Class I RecallMay 2024
Hikma Injectables USA Inc
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables US
Classification: Class I
Class III RecallMay 2024
Hikma Injectables USA Inc
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hik
Classification: Class III