95,018 total recalls in our database
R & S Roberts Enterprises
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent drug: Low OOS for menthol content at the three month room temperature.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
CGMP Deviations: Failure to properly investigate failed microbial testing.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Failure to properly investigate failed microbial testing.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
CGMP Deviations: Failure to properly investigate failed microbial testing.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Lupin Pharmaceuticals
Failed Stability Specification
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Beckman Coulter
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
The device was not cleared for U.S. distribution.
Beckman Coulter
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere