Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Family Dollar Saline Nasal Spray 4.25 oz. can
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Finafta Baby
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rhinall Nasal Decongestant Nasal Spray
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Walgreens
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Walgreens
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Well at Walgreens
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Walgreens
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Walgreens
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Best Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Best Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Best Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Best Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
OCEAN Saline Nasal Spray
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
TopCare
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Thayers Natural Remedies
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Thayers Natural Remedies
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rite Aid Pharmacy
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
QC Quality Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
QC Quality Choice
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Premier Value
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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