  |
Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Balanced Solutions Compounding Pharmacy, LLC 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. See the Press Release for a listing of affected products.
BACKGROUND: These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were furnished nationwide. The sterile products include all injectables with the Balanced Solutions Compounding Pharmacy name.
RECOMMENDATION: 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 pharmacist@xxxxxxxxx. Patients who have received any product furnished by Balanced Solutions Compounding Pharmacy and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
