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CGMP Deviations: Potential risk of Cross Contamination
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
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.
Labeling: Not elsewhere classified
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Subpotent Drug
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
CGMP DEVIATIONS
CGMP Deviations: Potential product carryover.
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Lack of Assurance of Sterility