Class II · Moderate risk Terminated
Amphotericin B Liposome for Injection
Reason Subpotent drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 II · Moderate risk Completed
Pain Reliever
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
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
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