Mylan and Hospira are both recalling injected medications because potentially dangerous particulate has been discovered in them. Mylan is recalling a chemotherapy drug, while Hospira is recalling a solution often used to treat diabetes.
Mylan on Monday issued a voluntary nationwide recall of two lots of levoleucovorin injection, 250 mg/25 mL to the user level that were actually manufactured by Indian drugmaker Alidac Pharmaceuticals but distributed by Mylan Institutional.
The drug, which is often used to prevent the side effects of methotrexate in patients with bone cancer, is being recalled because copper salts were found in samples during 12-month stability testing.
Pfizer’s Hospira is recalling three lots of 8.4% sodium bicarbonate injection 1 mEq/mL to the hospital level after confirming there was glass particles in some vials, the company said. The drug was produced at its Rocky Mount, North Carolina plant.
Neither company has had any reports of adverse reactions to the injections but both warned of the potential dangers which run the gamut from local irritation to the potential for pulmonary embolism. In an email Pfizer said a health hazard assessment determined the risk from the particulate is very low.
While the Rocky Mount plant had regulatory problems in the past, it has been free of issues from some years. The recall, however, comes as the company has been dealing with manufacturing problems at a couple of other Hospira injectables plants. The FDA this month issued a warning letter to an injectables plant in Irungattukottai, India, that Pfizer has announced it is closing after halting production there last year.
While the FDA found problems at the facility tied to employees manipulating testing data, Pfizer has said the decision to close the Irungattukottai site, as well as another site in Aurangabad, was actually due to significant long-term loss of demand for the products they make.
Pfizer also continues to make improvements at an injectables facility in Kansas that supplies many essential products to hospitals in the U.S. That plant was issued a warning letter in 2017.