Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots 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
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
Nortriptyline HCL capsules
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
Class II · Moderate risk
Chlorhexidine Gluconate Oral Rinse USP 0.12%
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Busulfan Injection 60 mg/10 mL
CGMP Deviations
Class II · Moderate risk
Zapien Productos Hand Sanitizer Gel Antibacterial
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk
CVS Health Hydrating Healing Ointment
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class II · Moderate risk
Vapor Ointment packaged in a) 1/8 oz
CGMP Deviations
Class II · Moderate risk
White Liniment packaged in a) 1 oz
CGMP Deviations
Class II · Moderate risk
Union (black)
CGMP Deviations
Class II · Moderate risk
Salicylic Acid Shampoo 3%
GMP Deviations
Class II · Moderate risk
DCL Clear Skin Anti-Blemish Hydrator
GMP Deviations
Class II · Moderate risk
DCL Alpha Beta Gel Toner
GMP Deviations
Class II · Moderate risk
Willa Pore Perfector
GMP Deviations
Class II · Moderate risk
Willa Clear Skin
GMP Deviations
Class II · Moderate risk
MD Complete Breakout Treatment
GMP Deviations
Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
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