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.
FDA Drug Recalls
94 recalls · Class III, newest first
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 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 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.
Class III · Low risk
Discount Drug Mart
Labeling: Incorrect or Missing Lot and/or Expiration date.
Class III · Low risk
TRAMADOL HYDROCHLORIDE Tablets
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 III · Low risk
Frovatriptan Succinate Tablets
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 III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class III · Low risk
Clonidine Hydrochloride Tablets
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Class III · Low risk
Tramadol Hydrochloride Tablets USP CIV
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 III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class III · Low risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Class III · Low risk
Montelukast Sodium Chewable Tablets
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Class III · Low risk
Magnesium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
methylPREDNISolone Sodium Succinate For Injection
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Class III · Low risk
Tri-Lo-Marzia
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class III · Low risk
Eczema Skin Relief Lotion
Microbial contamination of non-sterile product.