10 FDA recalls mention Yeast. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Yeast.
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Marketed Without an Approved NDA/ANDA
Reason cGMP violations
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Reason Microbial contamination
Reason Microbial contamination
Reason Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Reason Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making…
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