CGMP DEVIATIONS
Other Drugs
💊 Drugs • 3,313 recalls
CGMP Deviations
CGMP DEVIATIONS
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP DEVIATIONS
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.
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Consolidated Chemical
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
Consolidated Chemical
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Urban Electric Power
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
cGMP Deviations
cGMP Deviations
cGMP Deviations
Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
GFA Production Xiamen Co.
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.