13 FDA recalls mention Olopatadine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Olopatadine.
Reason Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason CGMP Deviations: products were stored outside the drug label specifications.
Reason Lack of Assurance of Sterility
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