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Able Labs Suspends Manufacturing, Recalls Products

Jessica Perry//May 23, 2005

Able Labs Suspends Manufacturing, Recalls Products

Jessica Perry//May 23, 2005

Company also plans to withdraw seven of its applications with U.S. regulators to market new products.Able Laboratories (Nasdaq: ABRX), a Cranbury maker of generic drugs, said Monday it has suspended manufacturing operations and recalled its product line because of improper laboratory practices and noncompliance with standard operating procedures.

The announcement follows the company”s decision last week to temporarily suspend shipment of products. The same day, Able announced the resignation of its chairman and CEO, Dhananjay G. Wadekar, and withdrew its financial outlook.

In a press release, Able said it is suspending manufacturing operations as an additional precaution while its internal investigation of manufacturing practices continues.

The company also said it intends to withdraw seven of its applications with U.S. regulators to market new products. Able said it expects the disruption to have a “material adverse effect” on its business and results.

Able announced the internal review of its operating practices in its quarterly report for the period ended March 31. Working with internal management resources, outside consultants and the FDA, the company identified apparent departures from standard operating procedures with respect to certain laboratory testing practices.

At the close of trading, Able shares were down $2.14 to $5.05.

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