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Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: 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
BACKGROUND: 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. ApothéCure’s sterile products covered under this recall were distributed nationwide and supplied to the offices of licensed medical professionals. 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.
RECOMMENDATION: 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 pharmacist@xxxxxxxxxxxxxx. Patients who have received any product distributed by Apothe’Cure and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348170.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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