Overview of recall records associated with Akorn, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 100, Class III: 27.
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."…
Subpotent Drug: Low out-of-specification potency result of the drug product.
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.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
This page summarizes recall records in which the official source identifies Akorn, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
