Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility
Audience: Consumers, Pharmacy
ISSUE: Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table in press release) due to 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.
BACKGROUND: 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.
RECOMMENDATION: Medaus is notifying its customers by telephone and email, and is arranging for return of affected products. Health care 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 a.m. and 5 p.m. CDT.
Healthcare professionals and patients are encouraged 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:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form 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
[09/05/2013 - Firm Press Release - Madeus]
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