Class II · Moderate risk
Peppermint Lip Moisturizer
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class II · Moderate risk
Sunstar GUM Toothpaste 3 g tubes
cGMP Deviation
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class II · Moderate risk
Elelyso (taliglucerase alfa)
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class III · Low risk
Zoledronic Acid Injection 5 mg/100 mL
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
Lack Of Processing Controls
Class III · Low risk
CVS Health Sodium Chloride Ophthalmic Ointment USP
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Class III · Low risk
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Class III · Low risk
Sodium Chloride Ophthalmic Ointment USP
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class II · Moderate risk
Desoximetasone Topical Spray
Failed Impurities/Degradation Specification; high out of specification results observed
Class III · Low risk
Potassium Chloride Extended-Release Tablets USP
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.