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…

Recall date

February 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0420-2015

FDA classification

Class III

Brand / firm

West-Ward Pharmaceutical Corporation

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; 12 month stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.