Product: PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 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