ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
22 recalls, newest first
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
GMP deficiencies
GMP Deviations
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
GMP deviation; Sr-82 levels exceeded alert limit specification
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.
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.
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.