Indianapolis-based pharmacy issues recall over compounded drugs

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INDIANAPOLIS – An Indianapolis-based pharmacy is recalling nearly 100 compounded drugs after a federal inspection identified potential safety risks.

The recall from Nora Apothecary & Alternative Therapies affects drugs that have not yet reached their expiration date. The drugs were made on or before April 19.

The company wrote that the recall “is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance.” Patients could be at an increased risk for serious infection if the sterility of the compounded drugs has been compromised. The company said it has not received any reports of problems or illnesses associated with the drugs.

The pharmacy called patient safety its “highest priority” and said the recall was voluntary.

The products under recall were supplied to patients and offices of licensed medical professionals. Approximately 95 dosage units went to medical professionals and may have been dispensed to people who live out of state. The recall also includes about 400 prescriptions compounded for patients in Indiana, Illinois, Ohio, Florida and Tennessee.

Anyone with questions should call 800-729-0276 or 317-251-9547 from the hours of 9:30 a.m. to 6 p.m. Monday through Friday. You can also send email to the following address: pharmacist@noraapothecary.com. Patients who are concerned about products furnished by Nora Apothecary & Alternative Therapies should contact their healthcare provider.

The company will contact customers to let them know to return the products.

Adverse reactions or problems with the company’s products can be reported to the FDA via the web, mail or fax:

Online: www.fda.gov/medwatch/report.htm
Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm
Fax: 1-800-FDA-0178

The FDA is inspecting compounding pharmacies around the country following a deadly meningitis outbreak that originated from a Massachusetts compounding pharmacy.