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: recalling drug products following an FDA inspection.
Reason Labeling: Missing label: Label missing from some prefilled pens.
Reason Labeling: Missing label on the vial
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Reason Presence of foreign substance: Presence of stainless steel particulates in tablets.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason Superpotent and Failed Tablet/Capsule Specifications
Reason CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason Failed Dissolution Specifications: results were above specification.
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason Presence of foreign substance: identified as activated carbon.
Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Reason Microbial Contamination of Non-Sterile Product
Reason Failed Moisture Limits: Out of specification for water content
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a…
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