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Recall Enforment Report D-0174-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hikma Injectables USA Inc, originally initiated on 12-19-2024 for the product phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 The product was recalled due to lack of assurance of sterility: the tamper-evident seal on several of the syringes are not attached upon receipt of shipment.. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0174-202512-19-202401-08-2025Class IIphenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.Completed
D-0173-202512-19-202401-08-2025Class II1,800 syringesketamine 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., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.Completed