Medaus Pharmacy Initiates Nationwide Recall of Certain Pharmacy Products Due to Questions Surrounding an Independent Third Party’s Sterility Testing
BIRMINGHAM, Ala. (PRWEB) September 04, 2013 -- Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products due to our 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 we demand from ourselves and on behalf of our 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.
The below products are included in this recall:
Testosterone CYP 200 mg/mL, Lot # 130508-1, Exp. 11/16/2013
Lipo injection with lidocaine, Lot # 130510-26, Exp. 11/16/2013
Lipo injection with lidocaine, Lot # 130610-24, Exp. 12/7/2013
Taurine 50 mg/mL PF, Lot # 130618-64, Exp. 12/15/2013
L-Glutathione 200 mg/mL, Lot # 130617-10, Exp. 12/14/2013
Pyridoxine HCl 100 mg/mL NS PF, Lot # 130531-31, Exp. 11/27/2013
Magnesium CHI 200 mg/mL, Lot # 130307-60, Exp. 9/3/2013
Sodium ascorbate 500 mg/mL PF, Lot # 130702-1, Exp. 12/29/2013
Lipo injection with lidocaine, Lot # 130709-68, Exp. 1/5/2014
Sodium ascorbate 500 mg/mL non-corn PF, Lot # 130613-8, Exp. 12/10/2013
These products were dispensed between March 12 and July 22, 2013, throughout the United States. We 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. 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.
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
Media Contact: 205-327-8388
Greg Turner, +1 617-243-9950, [email protected]
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