Able suspends manufacturing, recalls all products

After announcing several product recalls earlier this year due to various improper laboratory practices and noncompliance with standard operating procedures, Able notified the FDA and began conducting an internal review of its operating practices, as initially announced in its quarterly report on Form 10-Q for the quarter ended March 31, 2005.

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. As a result of these observations, Able recently suspended shipment of its products.

As an additional precaution while its investigation proceeds, the company has now suspended the manufacture and distribution of its products until it can ensure that the products are manufactured and tested in compliance with standard operating procedures and current good manufacturing practices.

Able also intends to withdraw seven of its approved abbreviated new drug applications (ANDAs) filed with the FDA for various reasons, including commercial reasons and the identification, in certain applications, of data upon which the company is no longer willing to rely.

As part of its ongoing investigation, the company will continue to review its entire ANDA portfolio and will withdraw other previously approved and pending ANDA applications if it identifies further data upon which the company is not willing to rely.

Able said it does not, at this time, know what further actions it may have to take or what actions the FDA and other government officials may undertake. However, this disruption in business is expected to have a material adverse effect on its business and financial results.