Class II · Moderate risk
Premier Value
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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
Premier Value
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.
Class II · Moderate risk
Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
HuMist Saline Nasal Mist 1.5 FL OZ
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Meijer
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
meijer
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Harmon Face Values
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Harmon Face Values
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
FAMILY wellness
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
DG health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Discount Drug Mart
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
CareOne
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rhinall (phenylephrine hydrochloride)
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
10 mg/mL Rocuronium Bromide
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
5 mg/mL Ephedrine Sulfate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
10 mcg/mL Fentanyl Citrate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
Eyewash Purified water 98.3%
CGMP Deviations
Class II · Moderate risk
Emergency First Aid Eyewash
CGMP Deviations
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