Premier Pharmacy Labs, a sterile compounding pharmacy, has issued a nationwide recall of nearly two dozen unexpired drugs following a recent inspection by the U.S. Food and Drug Administration.
The voluntary recall applies to medications that are intended to be sterile.
Premier Pharmacy Labs is recalling the drugs due to a lack of sterility assurance, based on concerns voiced at the FDA inspection. During the inspection, the agency raised concerns related to insufficient environmental controls, potential cross-contamination and lack of product-specific process validations.
The inspection took place April 20 to June 12.
Premier Pharmacy Labs said it is not aware of any adverse events related to the drugs in question, which were distributed between January 18 and April 24.
However, the company is recalling the products since administering medications that aren't sterile could result in serious, life-threatening infections, Premier Pharmacy Labs said in a statement Thursday.
Premier Pharmacy Labs—which works with hospitals, surgery centers and physician clinics—said customers in possession of the affected medications should quarantine the product, discontinue use and destroy per the respective organization's protocol.
This is the second voluntary recall Premier Pharmacy Labs has issued as a result of potential lack of sterility assurance since last spring.
The company in April 2018 recalled lots of four sterile injectable products after detecting microbial contamination during routine testing of subsequent, unreleased product lots.