Overview of recall records associated with Asclemed USA Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3, Class III: 1.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
This page summarizes recall records in which the official source identifies Asclemed USA 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.
