Product: HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Reason for recall: Lack of assurance of sterility: Product bags leaking at seam.
Recall initiated: 20170518
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated