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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.
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Subpotent Drug: Low out-of-specification potency result of the drug product.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point