1,709 recalls · Class III, newest first
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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.
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.
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.
Reason Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date.
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.
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.
Reason Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Reason 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.
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.
Reason Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Reason Failed Dissolution Specifications: low out of specification results for dissolution testing.
Reason Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Reason Lack of Assurance of Sterility
Reason 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.
Reason CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Reason Microbial contamination of non-sterile product.
Reason Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Reason Superpotent Drug: Salicylic acid content is above the firm's specification.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.