Recalls / Class III
Class IIID-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.
- 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 #: 113312, Exp 11/2015; 014315 Exp 01/2016
Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing.
Recalling firm
- Firm
- West-Ward Pharmaceutical Corporation
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 445,475 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-16
- FDA classified
- 2015-03-20
- Posted by FDA
- 2015-04-01
- Terminated
- 2016-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0420-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.