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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.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
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 impurity, D-aspartic acid.
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 point.
Failed Stability Specification: out of specification results for Sodium Perborate
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
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
CGMP Deviations