West-Ward Pharmaceutical Corporation recalls Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or I
Recalled April 1, 2015 · FDA recall D-0420-2015 · West-Ward Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications; 12 month stability testing. · FDA Class III
Units
445,475 Vials
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; 12 month stability testing.
Product
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Manufacturer(s)
West-Ward Pharmaceutical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →