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.
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.
Consumers or healthcare 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 protected]
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.