Product: Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, 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