17 FDA recalls mention Cedar. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cedar.
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could…
Reason Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net…
Reason Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Reason Lack of Assurance of Sterility
Reason Non Sterility: Microbial contamination
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