Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing
Contact:
Consumer:
800-526-9183
Media
205-837-7197
Consumer:
800-526-9183
Media
205-837-7197
FOR IMMEDIATE RELEASE - September 4, 2013 - Birmingham, Alabama, Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table) 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.
| Product Name | Lot # | Expiry |
|---|---|---|
| Testosterone CYP 200 mg/mL | 130508-1 | 11/16/2013 |
| Lipo injection with lidocaine | 130510-26 | 11/16/2013 |
| Lipo injection with lidocaine | 130610-24 | 12/7/2013 |
| Taurine 50 mg/mL PF | 130618-64 | 12/15/2013 |
| L-Glutathione 200 mg/mL | 130617-10 | 12/14/2013 |
| Pyridoxine HCl 100 mg/mL NS PF | 130531-31 | 11/27/2013 |
| Magnesium CHI 200 mg/mL | 130307-60 | 9/3/2013 |
| Sodium ascorbate 500 mg/mL PF | 130702-1 | 12/29/2013 |
| Lipo injection with lidocaine | 130709-68 | 1/5/2014 |
| Sodium ascorbate 500 mg/mL non- corn PF | 130613-8 | 12/10/2013 |
These products were dispensed between March 12 and July 22nd, 2013 nationwide 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.
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