Recall: D-1139-2015

Class III - Minor Violations

Class IIIClassification

2015-05-13Initiated

TerminatedStatus

West-Ward Pharmaceutical Corp.Firm

Product

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.

Reason

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

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.