Loading...
Loading...
All product recalls associated with Akorn, Inc..
Total Recalls
192
Past Year
0
Class I (Serious)
0
Most Recent
Apr 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Product is being recalled due to low pH value.
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Failed Dissolution Specifications
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Subpotent Drug: concentration of product is less than labeled amount.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Presence of Particulate Matter
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.