FDA 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).

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-05-13

Report date

2015-06-24

Termination date

2016-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2015