Class II · Moderate risk Terminated
Carbidopa and Levodopa Tablets
Reason Product Mix-Up: A foreign tablet was found in bottle.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Sunstar GUM Toothpaste 3 g tubes
Reason cGMP Deviation
Class III · Low risk Terminated
Quetiapine Fumarate Extended-Release Tablets
Reason 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 Terminated
Quetiapine Fumarate Extended-Release Tablets
Reason 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 Terminated
Quetiapine Fumarate Extended-Release Tablets
Reason 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 Terminated
Quetiapine Fumarate Extended-Release Tablets
Reason 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 Terminated
Elelyso
Reason 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 Terminated
Zoledronic Acid Injection 5 mg/100 mL
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class II · Moderate risk Terminated
Morphine Sulfate
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Daptomycin
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Morphine Sulfate
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Acetylcysteine Ophthalmic 10% Solution
Reason Lack Of Processing Controls
Class III · Low risk Terminated
CVS Health Sodium Chloride Ophthalmic Ointment USP
Reason 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 Terminated
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP
Reason 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 Terminated
Sodium Chloride Ophthalmic Ointment USP
Reason 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 Terminated
Mesalamine Delayed-Release Tablets
Reason Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class II · Moderate risk Terminated
Desoximetasone Topical Spray
Reason Failed Impurities/Degradation Specification; high out of specification results observed
Class III · Low risk Terminated
Potassium Chloride Extended-Release Tablets USP
Reason Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Class III · Low risk Terminated
Discount Drug Mart
Reason Labeling: Incorrect or Missing Lot and/or Expiration date.
Class III · Low risk Terminated
TRAMADOL HYDROCHLORIDE Tablets
Reason Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Class II · Moderate risk Terminated
Memantine Hydrochloride Extended Release Capsules
Reason Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class III · Low risk Terminated
Frovatriptan Succinate Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Class I · High risk Terminated
Phenytoin Oral Suspension USP
Reason Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.