FDA recall D-1327-2016

Pharmakon Pharmaceuticals, Inc. · Class II · drug

Product

Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70

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-1327-2016