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Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products due to an 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 standards.
More specifically, which were dispensed between March 12 and July 22, 2013, and which are subject to the recall are as follows:
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. Nevertheless, Medaus is notifying its customers by telephone and email, and is arranging for return of affected products. According to the US Food and Drug Administration (FDA), health care facilities and customers in possession of products that 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 a.m. and 5 p.m. CDT.
In addition, the FDA as asked healthcare professionals and patients 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 by using online at www.fda.gov/MedWatch/report.htm 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