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All product recalls associated with AVKARE Inc..
Total Recalls
38
Past Year
0
Class I (Serious)
1
Most Recent
Jul 2022
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Labeling: Label Error on Declared Strength
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Failed Dissolution Specifications
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Failed Stability Specifications.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified