FDA 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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-02-16

Report date

2015-04-01

Termination date

2016-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2015