Class II · Moderate risk
Strophanthus hisp 30X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Other failed specifications
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present.
394 FDA drug recalls with this cause, newest first.
Every drug has a specification sheet: pH, viscosity, moisture, tablet hardness, colour, fill volume, disintegration time. A lot that misses any of them is out of specification, even when the active ingredient is present in the right amount. These recalls include discoloured tablets, crystals forming in a solution, capsules that split, and short-filled containers. They are rarely Class I, but they signal a process that has drifted.
Class II · Moderate risk
Strophanthus hisp 30X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE 1015 Formula
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE 1013 Formula Antimicrobial - F&M
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE-1035 Formula
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic…
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Viola od 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Quebracho 4C
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Cistus Canadensis 5X Coldness* 20% Alcohol drops
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Althaea 30X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Althaea 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Althaea 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Althaea Officinalis 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Kali Sulphuricum 3X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
La Core LCL-2-0191 Blend
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Viola Odorata 4X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Verbena Officinalis 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Quebracho 4C
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Humulus 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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