The Compounding Pharmacy of America recalls PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Kn
Recalled September 23, 2015 · FDA recall D-1622-2015 · The Compounding Pharmacy of America
Hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility · FDA Class II
Units
195 ml total volume
Sold at
Nationwide
Description
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product
PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer(s)
The Compounding Pharmacy of America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →