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
832 recalls, newest first
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.
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 II · Moderate risk
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
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 I · High risk
Phenytoin Oral Suspension USP
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.