Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class II · Moderate risk Terminated
Cisplatin Injection
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
EPINEPHrine 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Oxytocin 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason CGMP violations
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Ryaltris
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk Ongoing
Pluvicto
Reason CGMP deviations
Class II · Moderate risk Ongoing
EnviroClean Hand Sanitizer Gel
Reason CGMP deviations
Class II · Moderate risk Ongoing
Refresh LACRI-LUBE
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Ongoing
Refresh P.M.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Terminated
Proparacaine Hydrochloride Ophthalmic Solution
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion