Product: PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
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