FDA recall D-1166-2017

Product

Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52

Reason for recall

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-06

Report date

2017-09-27

Termination date

2020-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1166-2017