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.

Recall Number: D-1568-2014

Firm: Pharmakon Pharmaceuticals

Classification: Class I

Status: Terminated

Report Date: 20140903

Initiation Date: 20140421

Termination Date: 20141203

Reason for Recall

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Product Description

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.