A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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