Recalls / Class III
Class IIID-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.
- Brand name
- Fentanyl Citrate
- Generic name
- Fentanyl Citrate
- Active ingredient
- Fentanyl Citrate
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-6027, 0641-6024, 0641-6025, 0641-6028, 0641-6026, 0641-6029, 0641-6030, 0641-6247, 0641-6248, 0641-6249
- FDA application
- NDA019101
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Recalling firm
- Firm
- West-Ward Pharmaceutical Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 14,649 Cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-13
- FDA classified
- 2015-06-16
- Posted by FDA
- 2015-06-24
- Terminated
- 2016-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1139-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.