FDA recall D-1279-2016

Pharmakon Pharmaceuticals, Inc. · Class II · drug

Product

Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Key facts

Status
Terminated
Initiation date
2016-04-20
Report date
2016-07-20
Termination date
2018-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2016