FDAFebruary 16, 2015drug

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.

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

The hazard

Failed Impurities/Degradation Specifications; 12 month stability testing.

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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