Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.
161 recalls in this category, newest first.
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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)
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)
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)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
CGMP Deviations
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