Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance” FDA (2018).
FDA report “Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. 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. Review the press release for a list of affected products. https://www.fda.gov/Safety/Recalls/ucm604410.htm
Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome.”Full Text