Overview of recall records associated with Akorn, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 77, Class III: 2.
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.
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.
