FDA recall D-0755-2016

Hartley Medical Center Pharmacy, Incorporated · Class II · drug

Product

Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide. No foreign distribution.

Key facts

Status
Terminated
Initiation date
2016-02-04
Report date
2016-03-16
Termination date
2016-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Long Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0755-2016