Teva ($TEVA) is recalling nearly 43,000 bottles of paricalcitol, a drug used by dialysis patients. But in this case, Teva didn’t manufacture them. They were produced by Pharmaceutics International Inc., or Pii, a U.S. CMO that recently ran into problems with European regulators.
According to the most recent FDA Enforcement Report, Teva is recalling 42,969 bottles of paricalcitol in three dose sizes in 30-count bottles, 32,015 of 1 mcg bottles; 5,556 of 2 mcg bottles and 5,398 of 4 mcg bottles. Paricalcitol is used to treat and prevent overactive parathyroid glands in patients with chronic kidney disease who are on dialysis.
The voluntary recall, which began several weeks ago, was initiated because the products failed stability testing for impurity levels.
The paricalcitol, the FDA report says, was manufactured by Hunt Valley, MD-based Pii. Several months ago, the European Medicines Agency said it was pulling the manufacturing certification for the contract manufacturer after inspectors noted a number of problems. In the critical category was Pii’s failure to minimize the risk of cross-contamination between hazardous and non-hazardous products, the report said. Inspectors also noted the facility had an unqualified HPLC system and unacceptable approach to production equipment qualification.
In response, the company “brought in a team of experts” to address each area of concern and says it is giving the EMA’s action top priority.
While this recall falls on Pii, Teva is facing manufacturing concerns of its own. The FDA last week issued a warning letter to Teva’ sterile manufacturing plant in Hungary, a facility that earlier this year was banned from exporting most products to the U.S. Teva says it is conscientiously addressing the the FDA’s concerns and their underlying causes.
– access the recall report here
thanks to: FiercePharma