FDA recall D-1567-2014

Pharmakon Pharmaceuticals · Class II · drug

Product

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.

Reason for recall

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Distribution

United States: TX, IL, MD, IN

Key facts

Status: Terminated
Initiation date: 2014-04-21
Report date: 2014-09-03
Termination date: 2014-12-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1567-2014