FDA Drug Class II — Moderate

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 70004-0229-32

Hazard

Lack of assurance of sterility: Product bags leaking at seam.

Products

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 Pharmaceu
Brand
SCA Pharmaceuticals
UPC
LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17

Units Affected

118 bags