Denton Pharma Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count recall — FDA D-0057-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Overview of recall records associated with Denton Pharma, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
This page summarizes recall records in which the official source identifies Denton Pharma, 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.