Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
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
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Cleaning Solutions Foaming Hand Sanitizer
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk
Class II · Moderate risk
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodum Tablets USP 220 mg
CGMP Deviations
Class II · Moderate risk
Ethosuximide Oral Solution USP 250 mg/5 mL
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class II · Moderate risk
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class II · Moderate risk
Nystatin Oral Suspension
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class II · Moderate risk
Azelaic Acid 99.0+% Micro 500 Grams
cGMP Deviations
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
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