FDA recall D-1568-2014

Pharmakon Pharmaceuticals · Class I · drug

Product

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.

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-1568-2014