Overview of recall records associated with Apotex Inc., including dates, categories and classifications where available.
Classification mix: Class II: 11, Class III: 2, Class I: 2.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
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.
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Failed Stability Specifications: product may not meet specification limit for assay test.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
This page summarizes recall records in which the official source identifies Apotex Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
