Nora Apothecary, Inc. Recall

Nora Apothecary, Inc., located at 1101 East 86th Street, Indianapolis, IN 46240, has informed the Indiana Board
of Pharmacy and the Food and Drug Administration that they have initiated a voluntary recall of compounded
products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday,
April 19, 2013.
The Indiana Board of Pharmacy has been working closely with the FDA in an effort to ensure that Hoosiers
receive safe and effective compounded medications. A Board of Pharmacy inspector observed violations
during an FDA-led inspection. After the FDA inspection, the Board of Pharmacy had the pharmacy cease all
sterile compounding activities until they remedied their deficiencies. The inspector advised the use of an
isolator to help achieve and maintain compliance with the Indiana Board of Pharmacy’s USP 797-based
standards. Since then, the inspector has verified the installation and certification of an isolator. Unannounced
follow up inspections will continue to be conducted.
The Indiana Board of Pharmacy has referred the matter to the Indiana Attorney General’s Office to investigate
whether or not there have been any federal violations that warrant license discipline.
The Board of Pharmacy continues to monitor all pharmacy activities, including compounding, in an effort to
protect public safety. The Indiana Professional Licensing Agency takes patient safety very seriously, and we
continue to be vigilant in protecting all 6.5 million Hoosiers.
For recall information please contact Nora Apothecary at (317) 251-9547 or 800-729-0276 or by email at
pharmacist@noraapothecary.com. Adverse reactions or quality problems experienced with the use of any Nora
Apothecary products may be reported to the FDA’s MedWatch Adverse Event Reporting program at
www.fda.gov/medwatch/report.htm.