💊 Drugs • 3,200 recalls
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Chemical contamination: Presence of benzene
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Chemical contamination: Presence of benzene
Chemical Contamination; presence of benzene.
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
The Harvard Drug Group LLC
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
The Harvard Drug Group LLC
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Omega & Delta Co.
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.