FDA Drug Class II — Moderate

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.

Hazard

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Products

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Littl
Brand
SCA Pharmaceuticals
UPC
Lot: 20170707@27, BUD: 10/5/2017

Units Affected

130 bags