Product: 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.
Reason for recall: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recall initiated: 20180725
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated