Medicine recalls
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| The United States: Premier Pharmacy Labs issues voluntary nationwide recall of all unexpired sterile drug product lots due to lack of sterility assurance |
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The US Food and Drug Administration (FDA) announces that Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The unexpired sterile drug product lots are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. The nationwide recall includes lots of sterile drug products to the consumer/user level.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Premier Pharmacy Labs has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
The scope of this recall is all commercially distributed product lots compounded in the Weeki Wachee, FL location currently within their labeled expiration date in response to an FDA concerns raised during the most recent inspection carried out from 29 Apr 2019 to 12 Jun 2019.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/premier-pharmacy-labs-issues-voluntary-nationwide-recall-all-unexpired-sterile-drug-product-lots-due
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company.
Ends/Wednesday, Jun 19, 2019
Issued at HKT 15:00
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