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All product recalls associated with Apotex Inc..
Total Recalls
45
Past Year
0
Class I (Serious)
2
Most Recent
May 2020
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.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Presence of foreign substance: glass particles
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Superpotent Drug: Product may not meet specifications throughout shelf life.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Failed Stability Specifications: product may not meet specification limit for assay test.
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.