Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Lack of Assurance of Sterility
cGMP deviations: product stored outside of labeled temperature requirements.
cGMP deviations
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
The microbial test result is found to be out of specification due to high yeast and mold counts.
Failed Impurities/Degradation Specifications.
Lack of assurance of sterility.