Recall -- Firm Press Release
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ApothéCure, Inc. Announces Voluntary Nationwide Recall of All Lots of All
Sterile Products Compounded, Repackaged, and Distributed by ApothéCure,
Inc. Due to Sterility Assurance Concerns
FOR IMMEDIATE RELEASE - April 15, 2013 - ApothéCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes.
In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections. To date, ApothéCure, Inc. has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the interest of our patients, ApothéCure, Inc. has decided to voluntarily proceed with this recall process.
These products were supplied to the offices of licensed medical professionals. ApothéCure’s sterile products covered under this recall were distributed nationwide. ApotheCure will be notifying customers by fax to return the products to the pharmacy. The sterile products include all injectables with the clear message, “Independently tested for sterility,” noted on the vials as well as the Apothe’Cure name. Consumers or Health Care providers with questions regarding this recall may contact ApothéCure, Inc. by phone at 800-969-6601 or 972-960-6601 from the hours of 9:30AM-6PM central time Monday-Friday or e-mail address at email@example.com. Patients who have received any product distributed by Apothe’Cure and have concerns should contact their healthcare provider.
Adverse reactions or quality problems experienced with the use of any of the recalled drugs 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.