FDA MedWatch - All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance

All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Nora Apothecary & Alternative Therapies announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection

BACKGROUND: The recall includes sterile products that Nora Apothecary & Alternative Therapies supplied to patients and offices of licensed medical professionals.  Specifically, the recall includes approximately 95 dosage units of sterile compounded products that the pharmacy supplied to offices of twelve licensed medical professionals located within Indiana.  Some patients that received products from those medical professionals may be live in states other than Indiana.  The recall also includes approximately 400 prescriptions compounded for patients within Indiana and four other states: four prescriptions for patients in Illinois; and one prescription each for patients in Ohio, Florida and Tennessee. See the firm press release for a list of products.

The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. To date, Nora has received no reports of injury or illness associated with the use of our sterile products. 

RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Nora Apothecary & Alternative Therapies by phone at 800-729-0276 or 317-251-9547 from the hours of 9:30AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: pharmacist@xxxxxxxxxxxxxxxxxx.  Patients who have received any product furnished by Nora Apothecary & Alternative Therapies 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 complete MedWatch Safety Alert, including a link to the Firm Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349112.htm

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

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