The Colorado based, Front Range Labs came under fire Monday when the FDA raised concerns about the reliability of the sterility results from the lab. The questionable methods used by Front Range Labs has resulted in the FDA alerting the Alabama compounding pharmacy, the Wellness Pharmacy that sterility results that were obtained at Front Range Labs may be inaccurate for six lots of medications, thus spawning a nationwide recall of the risky medication. Medicine that is not sterile but in fact has microbial contamination, puts patients at risk of contracting a life-threatening illness.
Doctors will often use compounding pharmacies like the Wellness pharmacy when they need the medication to be combined, mixed, or altered in some way to create a medication that is custom tailored to the individual medical needs of the patient. Commonly compounding is done when a patient has an allergy to a dye in a needed medication or the patient has an inability to swallow medication in pill form and needs it in liquid. In both scenarios, compounding circumvents the patients’ issues and allows them to get the needed medication. According to the FDA, “Compounded drugs are not FDA-approved. This means that FDA does not verify the quality, safety and effectiveness of compounded drugs. This also means that compounded drugs lack an FDA finding of manufacturing quality. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective.” That is why the independent testing done by labs like Front Range Labs is so important in assuring patient safety.
Recalled medications would have been distributed to patients and to doctors offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1ml to 50ml. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size. Wellness Pharmacy is notifying customers by telephone and regular mail of the recall. Patients and physicians are advised to immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy.
To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 a.m. and 4 p.m. CDT.