1,523 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…
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…
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…
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…
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…
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…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct…
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…
Reason Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing…
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…
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