Fallout from deficient findings at a contract testing laboratory used by dozens of pharmaceutical compounders continues to upend the compounding industry, with yet another company initiating a nationwide recall after it said it was unable to confirm whether its products are indeed sterile.
Background
In August 2013, the US Food and Drug Administration issued a statement that Loveland, CO-based Front Range Laboratories, Inc. had been observed to be using deficient methods to assess the sterility, strength and stability of products brought to it for testing.
"FDA has concerns that results obtained from Front Range are not reliable," FDA said in a statement. "FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."
Unlike previous inspections of compounding facilities by FDA, which generally focused on just a single company's products, Front Range's activities potentially affected more than 100 pharmacies across 32 US states, whose products could likely be found in all 50 states.
Three Initial Recalls
By 28 August 2013, FDA had announced the recall of products by three companies who had contracted with Front Range for Testing: Park Pharmacy & Compounding Center; Wellness Pharmacy, Inc; and JCB Laboratories.
"This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs … may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots," one of the companies, Wellness Pharmacy, wrote in its recall statement. "FDA has concerns that test results obtained from Front Range Labs may not be reliable."
The one piece of positive news from the recalls may have been their limited scope. Unlike some previous recalls, which affected dozens of products distributed over a lengthy period of time, the three recalls combined affected just 14 lots of product.
Fourth Pharmacy Recalls Products
Now FDA is confirming that a fourth company, Medaus Pharmacy of Birmingham, AL, has been affected due to deficient third-party testing.
"Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products 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," the company said in a statement. "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."
The company said that while it was unaware of any specific adverse events associated with its product, sterility lapses could hypothetically expose patients to serious life-threatening infections. Ten lots of eight different products are included in the recall.
The description of the lapses closely matches the account of Front Range, though the statement does not mention the company by name. Attempts to reach Medaus for comment were unsuccessful.
We've reached out to FDA for comment on whether the recall is related to Front Range or an as-yet-unknown second testing facility.
FDA Recall Notice
Medaus Recall Notice