West-Ward Pharmaceutical Corp. recalls Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25…

Recall date

May 13, 2015

Source

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

Recall number

D-1139-2015

FDA classification

Class III

Brand / firm

West-Ward Pharmaceutical Corp.

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

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), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.