Class II · Moderate risk Terminated
Mesalamine Delayed-Release Tablets
Reason Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Caduet
Reason 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.
Class II · Moderate risk Terminated
Caduet
Reason 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.
Class II · Moderate risk Terminated
Major Extra Strength Acetaminophen Tablets
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
Leader Extra Strength Acetaminophen Tablets
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
Fentanyl Citrate Inj.
Reason Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Class II · Moderate risk Terminated
New! Rompe Pecho MAX Multi Symptoms
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho EX Expectorant
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho CF Cold & Flu with Honey
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Ethacrynate Sodium for Injection
Reason cGMP Deviations
Class II · Moderate risk Terminated
Glycopyrrolate Tabs
Reason Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Class II · Moderate risk Terminated
Kushim Tablets
Reason Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Class II · Moderate risk Terminated
Methylphenidate hydrochloride Extended-Release ablets USP
Reason CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Methylphenidate hydrochloride Extended-Release ablets USP
Reason CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk Terminated
Olmesartan Medoxomil Tablets 20 mg
Reason cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.