Recalls, Resignations, and Suspended Manufacturing Plague Able Labs

Recalls, Resignations, and Suspended Manufacturing Plague Able Labs

Able Laboratories, Inc. (Cranbury, NJ) said late last week that it will halt all production and recall all available product because of problematic testing procedures discovered during an internal investigation.

Chairman and Chief Executive Dhananjay G. Wadekar announced his resignation shortly after the review, as company shares fell nearly 75%. Robert G. Mauro, Able’s president and chief operating officer, will assume the role of interim CEO.

According to a release from Able, the company also intends to withdraw seven of its approved abbreviated new drug applications (ANDAs). The company cited for various reasons for the withdrawl, including commercial reasons and the identification of unreliable data included in the filings.

As part of its ongoing investigation, Able will continue to review its entire ANDA portfolio and will may other previously approved and pending ANDA applications if it identifies further potentially inaccurate data.

At this time, the US Food and Drug Administration has taken any action against Able Labs.

–George Koroneos