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.