Product: Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
Reason for recall: Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated: 20170714
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated