FDA recall D-0189-2017

Cantrell Drug Company · Class II · drug

Product

Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61

Reason for recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-11-18
Report date
2016-12-21
Termination date
2020-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0189-2017