Drug recall D-0420-2015
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 for recall
Failed Impurities/Degradation Specifications; 12 month stability testing.
Lots and codes
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
Recall details
- Recalling firm
- West-Ward Pharmaceutical Corporation, Cherry Hill, NJ
- Quantity
- 445,475 Vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 16, 2015
- Terminated
- July 26, 2016
Related products
- Fentanyl Citrate – drug information
- NDC 0641-6030 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6027 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6249 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6029 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6248 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6028 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6247 Fentanyl Citrate · Fentanyl Citrate 50 ug/mL · Hikma Pharmaceuticals USA Inc.