Medisca Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient recall — FDA D-1174-2017
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Overview of recall records associated with Medisca, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5, Class I: 2.
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found…
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
This page summarizes recall records in which the official source identifies Medisca, 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.