ZTE-1035 Formula
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Most common reason: Failed specification (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Berberis. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
CGMP Deviations: products were not manufactured under current good manufacturing practices.
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