Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.
160 recalls in this category, newest first.
Reason CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
Reason CGMP Deviations
Reason Presence of Foreign Tablets/Capsules.
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Reason Failed Dissolution Specifications:
Reason CGMP Deviations
Reason Misprint on tablet
Reason Misprint on tablet
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Reason CGMP deviations.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Reason cGMP Deviations
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations
Reason CGMP Deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason Labeling: Label Mix-up
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
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