Sterile injectable products by Premier Pharmacy Labs: Recall—Lack of sterility assurance

FDA Apr 16, 2018

Issue

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 micro-organisms into the products.

Administration of nonsterile injection products that are intended to be sterile may result in a...

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General Medicine General Surgery Family Medicine

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