Class II · Moderate risk
Cistus Canadensis 6X
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
Cinnamomum 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Althaea Officinalis 4X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Cedar Fever Drops
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Haloderm Homeopathic Blend
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Yeast Guard Blend
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Occular Allergy Blend 87% Alcohol
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE-105 Formula Gentle Detoxing. Contents 1000 mL
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* 87% Alcohol HPUS: 5X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class III · Low risk
Avicel
Out of specification results for conductivity.
Class III · Low risk
Lidocaine Ointment USP
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class II · Moderate risk
Tizanidine HCl Tablets
Failed Tablet/Capsule Specification: Some tablets are shaved
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class III · Low risk
Metformin HCl Extended-Release Tablets
Failed Moisture Limits: Out of specification for water content
Class III · Low risk
Menopur 75 IU
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class I · High risk
Acyclovir Sodium Injection 500mg/10mL
Crystallization: customer complaints for crystallization in finished product.
Class I · High risk
Acyclovir Sodium Injection 1000mg/20mL
Crystallization: customer complaints for crystallization in finished product.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class III · Low risk
NDC 64380-721-06 Tacrolimus Capsules
Failed Moisture Limits
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk
Chlorhexidine Gluconate 20% 0012 Medichem
Discoloration.
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Tablet/Capsule Specification; complaint of bulging tablet
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