Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area
FOR IMMEDIATE RELEASE - May 6, 2013 - The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
In the event a sterile product is compromised patients are at risk for very serious infections. To date, The Compounding Shop has received no reports of injury or illness associated with the use of its sterile products. However, out of the abundance of caution and in the interest of the pharmacy's patients, The Compounding Shop has decided to voluntarily proceed with this recall process and to cease production of sterile products until further notice.
These products were supplied to the offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area. The Compounding Shop is notifying its customers by fax, phone or email to return products to the pharmacy. Consumers or health care providers with questions regarding this recall may contact The Compounding Shop at 727-381-9799 or toll free 866- 792-6731 Monday through Friday, 10:00 a.m. to 6:00 p.m. or by email email@example.com. Be advised, this recall does not pertain to any non-sterile compounded medications produced by the pharmacy. Patients who have received any product by The Compounding Shop 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.