Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products due to their inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence they demand from themselves and on behalf of their patients.
Though Medaus received test results indicating that these lots met all safety standards, they are being recalled because the independent testing lab’s sterility testing practices as applied to these lots indicate that the product’s sterility cannot be confirmed.
Therefore, Medaus decided to conduct this voluntary recall out of an abundance of caution.
The use of a non-sterile injectable product exposes patients to the risk of contracting serious life- threatening infections.
Medaus has not received any reports of adverse events related to the products affected by this recall to date.
In fact, Medaus has never in its history experienced a single adverse patient reaction attributable to a failure of Medaus safety standards or quality control.
For a list of pharmacy products being recalled, click here.
These products were dispensed between March 12 and July 22nd, 2013 throughout the United States.
They are contacting all patients and doctors offices that received these lots by phone to recall any unused medications from these lots.
Medaus is notifying its customers by telephone and email, and is arranging for return of affected products.
Healthcare facilities and customers that have products which are being recalled should stop using the product and call Medaus at 800-526-9183 for instructions on returning the product for a full refund.
To return medication or request assistance related to this recall, patients and physicians should contact Medaus Pharmacy at (800) 526-9183 , Monday through Friday, between 9 am and 5 pm 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.