Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
Lack Of Processing Controls
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 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 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.
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.
Class II · Moderate risk
Major Extra Strength Acetaminophen Tablets
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
Leader Extra Strength Acetaminophen Tablets
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
Fentanyl Citrate Inj.
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
New! Rompe Pecho MAX Multi Symptoms
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho EX Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu with Honey
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Ethacrynate Sodium for Injection
cGMP Deviations
Class II · Moderate risk
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Class II · Moderate risk
Kushim Tablets
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class II · Moderate risk
Atorvastatin Calcium Tablets
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
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP 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
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.