Class II · Moderate risk
Progesterone 200 mg Capsules 90 capsules
Lack of Processing Control
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
Progesterone/Versa Base 20 mg
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
Class II · Moderate risk
Estradiol 1.8 mg capsule 30 cap bottle
Lack of Processing Control
Class II · Moderate risk
Testosterone w/ Atrevis 100 mg/mL GEL
Lack of Processing Control
Class II · Moderate risk
Testosterone w/ Atrevis 20 mg
Lack of Processing Control
Class II · Moderate risk
Estradiol Vag Cream 0.01% Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Naltrexone
Lack of Processing Control
Class II · Moderate risk
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM
Lack of Processing Control
Class II · Moderate risk
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube
Lack of Processing Control
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class II · Moderate risk
Testosterone W/Cosmetic HRT Base 100 MG
Lack of Processing Control
Class II · Moderate risk
Estriol Vaginal Cream
Lack of Processing Control
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Sunstar GUM Toothpaste 3 g tubes
cGMP Deviation
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
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