Class II · Moderate risk
Max Packaging Antibacterial Towelette
CGMP Deviations
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
1) BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelette
CGMP Deviations
Class II · Moderate risk
Dukal BZK Antiseptic Towelette
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
Aq 120 Gfew
cGMP deviations.
Class II · Moderate risk
TPN bag (patient specific)
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Class II · Moderate risk
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Deodorant: a) Axe
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Petroleum jelly: a) Vaseline Petroleum Jelly
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Lucky Ice
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Personal Care
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Carmex a) jar
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Personal Care
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Swan
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
TUMS a) Assorted
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Halls Cough Drops a) BAGS
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
TYLENOL a) 500 MG.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Pepcid Complete - 25ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Pepto Bismol 32ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Children Nyquil
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Nyquil Cold & Flu -32ct/2pk
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
LIQUID NYQUIL a) regular
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Motrin 2's Disp.- 50ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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