Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Sotalol HCL Tablets
Reason Presence of particulate matter. presence of metal particles.
Class II · Moderate risk Terminated
Theophylline
Reason CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Class II · Moderate risk Terminated
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk Terminated
Epinephrine Injection USP
Reason CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Class II · Moderate risk Terminated
Sodium Chloride 0.9% Injection
Reason CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Class II · Moderate risk Terminated
Peppermint Lip Moisturizer
Reason Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Carbidopa and Levodopa Tablets
Reason Product Mix-Up: A foreign tablet was found in bottle.
Class II · Moderate risk Terminated
Sunstar GUM Toothpaste 3 g tubes
Reason cGMP Deviation
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 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 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 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 II · Moderate risk Terminated
Amoxicillin and Clavulanate Potassium Tablets
Reason Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.