Product: fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
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