Recall: D-0420-2015

Class III - Minor Violations

Class IIIClassification

2015-02-16Initiated

TerminatedStatus

West-Ward Pharmaceutical CorpoFirm

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.

Reason

Failed Impurities/Degradation Specifications; 12 month stability testing.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.