The Compounding Pharmacy of America recalls PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America
Recalled September 23, 2015 · FDA recall D-1621-2015 · 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
209 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 40 (Alprostadil) 40 mcg/ml Injection, ml, 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 →