BIRMINGHAM, Ala. (PRWEB) May 14, 2016
Medaus Pharmacy is voluntarily recalling all unexpired sterile injectable drug products to the consumer level.
Medaus is initiating the voluntary recall due to the FDA’s determination that the Company’s processes and protocols at the facility present a lack of sterility assurance. If any products intended to be sterile are not sterile, administration of such products could result in serious infections that may be life-threatening.
“The health and safety of our customers is and has been the most important part of our business for the nearly 20 years we’ve served the public,” said Steven Russell, RPh, CEO and President of Medaus. “We perform third-party sterility testing before releasing our sterile products, and no tests have yet identified a single compromised product we have shipped to a patient, nor have we ever had an adverse patient reaction due to lack of sterility.
“Even though we’ve had no reports of any problems with these products, and we believe we comply with strict standards applicable to pharmacy aseptic practices, we want to resolve this matter and recall the small number of products on the market and focus on serving our patients,” Mr. Russell said.
The recalled products are used for nutritional deficiencies, hormone replacement, metabolic disorders, environmental toxicities, sexual dysfunction and other medical conditions as determined by the physician and are packaged in either clear or amber glass vials with gray septum. The affected products include: vitamins, minerals, amino acids, hormones, chelating agents, vaso-active agents that are sterile injections within the expiration date.
The product can be identified by the label affixed to the vial with “Medaus Pharmacy” and the phone number (1-800-526-9183) printed on the lower half of the label. The product was distributed nationwide.
Medaus is notifying its distributors and customers by phone and letter and is arranging for the return of unused product. Consumers who have product subject to the recall should stop using it and contact the pharmacy.
To return medication or request assistance related to this recall, contact Medaus at 1-800-526-9183, Monday through Friday, between 9 a.m. and 5 p.m. CDT. Adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or fax.
- Online: http://www.fda.gov/MedWatch/report.htm
- Mail: use postage-paid, pre-addressed Form FDA 3500 at http://www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Consumer Contact: 800-526-9183; info(at)medaus(dot)com
Media Contact: 205-578-6928