Hikma Injectables recalls
FDA enforcement reports naming Hikma Injectables USA Inc as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 1
- Most recent report
- Jan 8, 2025
- Jan 8, 2025ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or…Drug · Hikma Injectables USA IncLack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.Class II
- Jan 8, 2025phenylephrine in 0Drug · Hikma Injectables USA IncLack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.Class II
- May 29, 2024Phenylephrine in 0Drug · Hikma Injectables USA IncLabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.Class I
- May 8, 2024Fentanyl 1000mcg/100mL (10mcg/mL) in 0Drug · Hikma Injectables USA IncLabeling: Wrong BarcodeClass III