Teva Recalling 'Superpotent' Drug for Parkinson's Disease

Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year.

The voluntary recall involves 1,000-count bottles of 25 mg/100 mg carbidopa/levodopa tablets, according to the FDA enforcement report last week. The agency described it as a class II recall, which is for products that may cause temporary or reversible adverse events, or where the probability of serious health consequences is remote.

Teva has recalled several other drugs this year, according to FDA enforcement reports, including nearly 130,000 cartons of Tev-Tropin growth hormone in June, due to potential chemical contamination, and more than 1 million bottles of duloxetine delayed-release capsules for anti-depression in April, citing a customer complaint on capsule breakage.

The Israel-based company was one of 13 drugmakers selected this year to participate in the FDA’s Secure Supply Chain Pilot Program. To qualify, the companies had to demonstrate an effective recall plan and other compliance-related abilities.

Make sure you avoid a costly recall by meeting good manufacturing practices for drug manufacturing. Train your staff on GMP’s the easy way with the Drug GMP Training Course: A 17-Module Customizable Training Series.