Overview of recall records associated with Akorn, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 100, Class III: 27.
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known…
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time…
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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.
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.
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
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.
Presence of Particulate Matter
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.
