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
sterile products include all injectables with the clear message, "Independently
tested for sterility,” noted on the vials as well as the ApothéCure 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 firstname.lastname@example.org. Patients who have
received any product distributed by ApothéCure and have concerns should contact
their healthcare provider.
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 HERE.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 4/16/2013)