Overview of recall records associated with Akorn, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 100, Class III: 27.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
CGMP Deviations:
CGMP Deviations:
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the…
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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…
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…
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.
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.
