Ranier's Compounding Laboratory recalls PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory
Recalled August 22, 2018 · FDA recall D-1091-2018 · 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
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
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.
Manufacturer(s)
Ranier's Compounding Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →