Overview of recall records associated with Apotex Corp., including dates, categories and classifications where available.
Classification mix: Class II: 17, Class III: 4, Class I: 4.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Failed Dissolution Specifications: Out of specification for dissolution.
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
This page summarizes recall records in which the official source identifies Apotex Corp. 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.
