Class II · Moderate risk
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
C-Semaglutide 5mg/mL injection
Lack of assurance of sterility.
Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Glimepiride USP
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Montelukast Sodium USP
CGMP deviations.
Class II · Moderate risk
Fast Acting Earwax Removal System
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Isopropyl Alcohol Antiseptic 75%
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Glimepiride Tablets USP
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Tadalafil Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.