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FDAMay 13, 2015drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

west ward pharmaceuticalwestwest ward

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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