💊 Drugs • 3,313 recalls
Denison Pharmaceuticals
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Denison Pharmaceuticals
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Denison Pharmaceuticals
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Aurobindo Pharma USA
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
CGMP DEVIATIONS
CGMP DEVIATIONS
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Non-Sterility
CGMP DEVIATIONS