D-0420-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2015
- Initiation Date
- February 16, 2015
- Termination Date
- July 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 445,475 Vials
Product Description
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 for Recall
Failed Impurities/Degradation Specifications; 12 month stability testing.
Distribution Pattern
Nationwide
Code Information
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016