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Hikma Injectables USA Inc FDA Recalls
4 recalls on file across drugs, 1 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults RoClass IIDec 19, 2024Lack of Assurance of Sterility: The tamper-evident seal on s |
| 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 IncClass IIDec 19, 2024Lack of Assurance of Sterility: The tamper-evident seal on s |
| Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: HikClass IIIApr 30, 2024Labeling: Wrong Barcode |
| Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USClass IApr 29, 2024Labeling: Label mix-up - ephedrine syringes mislabeled as ph |