Class II · Moderate risk Terminated
Amino Acid Injection 50 g/1000 mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Alcohol Swabsticks
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Sterile Alcohol Prep Pads
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Racepinephrine Inhalation Solution
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Dakin's Solution
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
A&D Original Ointment
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Pataday
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
GenTeal Tears
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Miralax
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Debrox
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Zaditor
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Balance
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Eye-stream
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Naphcon A eye drops
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Bisacodyl Suppositories
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Triple Antibiotic Ointment
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Telmisartan and Hydrochlorothiazide Tablets USP
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk Terminated
Telmisartan and Hydrochlorothiazide Tablets USP
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk Terminated
Testosterone Gel 1%
Reason Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution USP
Reason Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk Terminated
Launch Sequence Aphrodisia Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk Terminated
Launch Sequence Euphoria Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.