ApothéCure, Inc. Announces Recall, Sterility Assurance Concerns

On April 15, 2013, ApothéCure, Inc. announced a nationwide recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to the lack of sterility assurance and concerns over quality control processes. The FDA is aware of the recall.

ApothéCure has not received any reports of illness associated with the recalled product, but the pharmacy has decided to proceed with the recall to keep the best interest of it’s patients. If a sterile product is compromised, then patients are at risk for life threatening infections.

The recalled products were distributed and supplied to medical professionals nationwide. The pharmacy has notified it’s customers to return the products. Consumers and providers with any inquiries regarding the recall should contact the pharmacy by phone at 800-969-6601 or 972-960-6601 (9:30AM-6PM, Monday-Friday) or by email at [email protected].

Report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: FDA Medwatch
• 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