Class II · Moderate risk Terminated
Bebelyn Colic Drops Homeopathic Remedy
Reason cGMP deviations
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Arnica 7 Cream
Reason cGMP deviations
Class II · Moderate risk Terminated
Kanjo Homeopathic Pain Relief Cream With Arnica
Reason cGMP deviations
Class I · High risk Terminated
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Class II · Moderate risk Terminated
Amphotericin B Liposome for Injection
Reason Subpotent drug
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules
Reason Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class II · Moderate risk Terminated
Travoprost Ophthalmic Solution
Reason Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Class II · Moderate risk Terminated
Levsin injection
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
Sodium Chloride 0.9% Injection
Reason Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class III · Low risk Terminated
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Reason Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III · Low risk Terminated
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Foaming Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin and Tazobactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility