The Compounding Pharmacy of America recalls Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxv
Recalled September 23, 2015 · FDA recall D-1447-2015 · 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
44 mL total volume
Sold at
Nationwide
Description
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product
Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, 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 →