Class II · Moderate risk Terminated
Colgate Total SF Toothpaste
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Drug Recalls
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Class II · Moderate risk Terminated
CITALOPRAM Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
CHLORTHALIDONE Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Bumetanide Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Low Dose ASPIRIN
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Asmanex Twisthaler
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Armour Thyroid
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
AMOXICILLIN Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
AMOXICILLIN for Oral Suspension USP
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
ALLOPURINOL Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
ALBUTEROL SULFATE IN 90MCG per actuation
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
ALBUTEROL SULFATE HFA Inhalation Aerosol
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I · High risk Terminated
Revitaderm Wound Care Gel
Reason Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Class II · Moderate risk Terminated
Sinus Relief Headache/Nasal
Reason cGMP deviations
Class II · Moderate risk Terminated
Sinus Relief
Reason cGMP deviations
Class II · Moderate risk Terminated
REMfresh Advanced Ion-Powered Melatonin
Reason cGMP deviations
Class II · Moderate risk Terminated
REMfresh Advanced Ion-Powered Melatonin
Reason cGMP deviations
Class II · Moderate risk Terminated
ELECTROLYTE Supplement Tablets
Reason cGMP deviations
Class II · Moderate risk Terminated
Miralac
Reason cGMP deviations
Class II · Moderate risk Terminated
SINUS DECONGESTANT Nasal Decongestant
Reason cGMP deviations
Class II · Moderate risk Terminated
AYPANAL Non-aspirin Pain Reliever
Reason cGMP deviations
Class II · Moderate risk Terminated
CETAFEN Extra Non-Aspirin Pain Relieve
Reason cGMP deviations
Class II · Moderate risk Terminated
Cetafen Cough & Cold Cough & Cold Relief
Reason cGMP deviations