Fla. compounding pharmacy recalls sterile drugs
Apr 21, 2013, 5:14 PM
LAKE MARY, Fla. (AP) – A Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns the products are not sterile and may contain bacteria, Food and Drug Administration officials said Sunday.
The FDA encouraged health care facilities and providers who have received sterile products, including all injectables, from Balanced Solutions Compounding Pharmacy to immediately check their medical supplies, quarantine the products, and follow the company’s recall instructions. Patients who were administered any sterile drug products produced and distributed by Balanced Solutions should contact their health care providers.
The recall includes a few dozen sterile products furnished nationwide, according to a statement from the company. The majority of the products were injectable drugs.
An FDA inspection of the company revealed “poor practices and conditions which may have exposed the company’s sterile products to microbial contamination,” officials said in a statement.
The FDA sampled chromium chloride injections from Balanced Solutions and identified gram-negative bacteria in the product, which can cause disease and many types of infection. But officials said the bacteria do not usually cause infection in humans.
Balanced Solutions is a division of Axium Healthcare Pharmacy Inc., which is based in Lake Mary.
An email and phone call to the company were not immediately returned Sunday.
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