|An Attix facility--Courtesy of Attix|
A Canadian-based company that sources active pharmaceutical ingredients from China and repackages them in Toronto is recalling hundreds of bulk APIs sold in the past three years because the facility where they were packaged didn't adequately separate penicillin APIs from the rest.
According to Health Canada, Attix Pharmaceuticals is recalling all nonpenicillin APIs repackaged and distributed between Jan. 5, 2012, and Feb. 13, 2015. According to the most recent FDA Enforcement Report, that adds up to 479. The FDA says they were sold to research facilities and compounding pharmacies. Health Canada's inspection tracker indicates the company does not currently have a license and has voluntarily stopped selling product and quarantined what it has on hand.
The FDA has been inspecting and overseeing the country's largest compounders since a fungal meningitis outbreak in 2012 that was tied to now-bankrupt New England Compounding Center (NECC) infected 750 people, of which 64 died. Former owners and employees of the company have since been indicted, including two pharmacists who have been indicted for second-degree murder.
The FDA, granted more authority over the industry with a new law in 2013, has mostly focused on the largest compounders but in some cases has taken a look at companies that provide them services. In 2013 it cited 5 laboratories that tested products for about 90% of the nation's large-scale compounding pharmacies. Among those was the lab that tested the products for NECC as well as DynaLabs in St. Louis, MO, where it found bacteria in a clean room.
DynaLabs tested the calcium gluconate solution made by Texas-based Specialty Compounding that authorities now believe was contaminated with bacteria. The compounder recalled the drug after the Centers for Disease Control and Prevention (CDC) linked it to 17 illnesses at two Texas hospitals. A federal judge issued a permanent injunction in March against Specialty Compounding, preventing it from reopening until it makes upgrades that are approved by the FDA.