Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
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
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Class II · Moderate risk
Pro Numb Tattoo Numbing Spray
cGMP deviations
Class II · Moderate risk
Pro Numb Tattoo Numbing Spray
cGMP deviations
Class II · Moderate risk
Antimicrobial Alcohol Hand Wipe
CGMP Deviations
Class II · Moderate risk
Children's Healthcare of Atlanta
CGMP Deviations
Class II · Moderate risk
Dynarex
CGMP Deviations
Class II · Moderate risk
Dynarex
CGMP Deviations
Class II · Moderate risk
Green Guard Antiseptic Wipes
CGMP Deviations
Class II · Moderate risk
Hand Sanitizing Wipes
CGMP Deviations
Class II · Moderate risk
WP WipesPlus Hand Sanitizing Wipes
CGMP Deviations
Class II · Moderate risk
Med-Nap Cleansing Towelettes
CGMP Deviations
Class II · Moderate risk
Cleansing Towelette
CGMP Deviations
Class II · Moderate risk
Dynarex Obstetrical Towelettes Cleanser
CGMP Deviations
Class II · Moderate risk
Wipes Plus
CGMP Deviations
Class II · Moderate risk
BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
Med Nap BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
Medi-First Antiseptic Wipes
CGMP Deviations
Class II · Moderate risk
Savannah Antibacterial Towelettes
CGMP Deviations
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