Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance

Date of Recall

2013-04-20

Recall Details

- April 17, 2013 - Balanced Solutions Compounding Pharmacy, LLC today announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance.

Patients are at increased risk for infections in the event a sterile product is compromised. During a recent inspection the FDA sampled chromium chloride injection from Balanced Solutions Compounding Pharmacy and identified gram negative bacteria in the product, which Balanced Solutions Compounding Pharmacy, LLC had previously recalled. To date, Balanced Solutions Compounding Pharmacy, LLC has received no reports of injury or illness associated with the use of our sterile products. Patient safety is our highest priority and, out of an abundance of caution, we have decided to initiate this voluntary recall to include all lots of all sterile products within expiry. The affected products can be found at www.bshrx.com.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were furnished nationwide. Balanced Solutions Compounding Pharmacy, LLC will be notifying customers by phone, fax and/or mail to return the products to the pharmacy. The sterile products include all injectables with the Balanced Solutions Compounding Pharmacy name.

Consumers or Health Care providers with questions regarding this recall may contact Balanced Solutions Compounding Pharmacy, LLC by phone at 407-936-2998 or 877-306-0008 from the hours of 9:30AM- 6:00PM Eastern Standard Time Monday-Friday or e-mail address at [email protected]. Patients who have received any product furnished by Balanced Solutions Compounding Pharmacy and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of any Balanced Solutions Compounding Pharmacy products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:

www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

• Fax: 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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