Another Compounding Pharmacy in Trouble

All health care facilities and health care providers that have received sterile products from Balanced Solutions should quarantine the products and follow the recall instructions from Balanced Solutions, according to FDA.

The U.S. Food and Drug Administraion announced a voluntary nationwide recall by Balanced Solutions Compounding Pharmacy on April 21, the latest problem for compounding pharmacies nationwide. The ageny's announcement said all sterile non-expired products have been recalled "due to a lack of sterility assurance."

Balanced Solutions Compounding Pharmacy is a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., and "is voluntarily recalling all lots of its sterile non-expireddrug products due to a lack of sterility assurance and concerns with product quality controls," according to the agency.

All health care facilities and health care providers that have received sterile products from Balanced Solutions should quarantine the products and follow the recall instructions from Balanced Solutions. "Patients who were administered any sterile drug products produced and distributed by Balanced Solutions and who have concerns should contact their health care providers," its announcement stated.

FDA said investigators "observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination," and additional analysis confirmed problems.

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  • OHS Magazine Digital Edition - January 2019

    January 2019

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