Teva Pharmaceutical Industries Ltd. is issuing a Class II recall of one lot (3,881 bottles) of carbidopa/levodopa 25 mg/100 mg, a generic drug used to treat Parkinson’s disease, due to the potential for “superpotent” tablets. The lot in question was manufactured in Israel for distribution in the United States.
A Class II recall is defined by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The recall was initiated because there is question as to whether the tablets may contain too much of one of the active ingredients.
This marks the latest of a number significant Class II recalls for the company in 2014, including:
- April: over 1M bottles of the generic of Eli Lilly’s antidepressant Cymbalta, due to a customer complaint trend regarding capsule breakage.
- May: 38,858 bottles of drugs manufactured in India by Emcure Pharmaceuticals for the US market, due to non-adherence to CGMP (Current Good Manufacturing Practice). This recall included three separate drugs: glyburide and metformin hydrochloride tablets for diabetes, the anti-inflammatory indomethacin, and methyldopa for low blood pressure.
- June: 129,060 cartons of a human growth hormone for children, TEV-TROPIN, because they may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
According to Fierce Pharma Manufacturing, Teva is going through a major restructuring to cut about $2 billion in costs. CFO Eyal Desheh has told analysts that Teva intends to close roughly half of its 75 plants in the next four to five years, even as it builds new facilities in faster growing markets like Russia.
Read about the recall in Hebrew at Globes.