Ranier's Compounding Laboratory recalls Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vial
Recalled August 22, 2018 · FDA recall D-1083-2018 · Ranier's Compounding Laboratory
Hazard
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. · FDA Class II
Units
a) 1 vial; b) 1 vial
Sold at
Product was distributed within the state of Pennsylvania.
Description
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
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.
Manufacturer(s)
Ranier's Compounding Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →