Drug recall D-1139-2015
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 for recall
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Lots and codes
Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
Recall details
- Recalling firm
- West-Ward Pharmaceutical Corp., Eatontown, NJ
- Quantity
- 14,649 Cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 13, 2015
- Terminated
- April 6, 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.