Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Recall Number: D-1094-2018
Firm: Ranier's Compounding Laboratory
Classification: Class II
Status: Terminated
Report Date: 20180822
Initiation Date: 20180725
Termination Date: 20220901
Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Product Description
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.