Class II · Moderate risk
Debrox
CGMP Deviations: products were stored outside the drug label specifications.
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Systane Zaditor
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Balance
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Eye-stream
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Bisacodyl Suppositories
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
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
Telmisartan and Hydrochlorothiazide Tablets USP
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 III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Hydrogen Peroxide Topical Solution USP
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class I · High risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage