Class II · Moderate risk
Oxygen
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
Cardiogen-82
GMP deviation; Sr-82 levels exceeded alert limit specification
Class II · Moderate risk
Zemplar (paricalcitol)
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class III · Low risk
Azelastine HCl Nasal Solution
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.