Recall -- Firm Press Release
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Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance
FOR IMMEDIATE RELEASE - April 22, 2013 - Indianapolis, Indiana - Nora Apothecary & Alternative Therapies today 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 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. 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.
Patients are at increased risk for serious infections in the event a sterile product is compromised. To date, Nora 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 sterile products that are within their expiry periods.
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. A list of products is attached. Nora Apothecary & Alternative Therapies will be notifying customers by phone, fax, mail, or personal visits to return the products to the pharmacy.
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: email@example.com. Patients who have received any product furnished by Nora Apothecary & Alternative Therapies and have concerns should contact their healthcare provider.
Adverse reactions or quality problems experienced with the use of any Nora Apothecary & Alternative Therapies' 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.