Mylan Institutional Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg recall — FDA D-0860-2022
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Overview of recall records associated with Mylan Institutional, Inc. (d.b.a. UDL Laboratories), including dates, categories and classifications where available.
Classification mix: Class II: 2.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
This page summarizes recall records in which the official source identifies Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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.