COMPANY RECALLS REPACKAGED DRUGS, CLOSES FACILITY AFTER WARNING LETTER

The FDA warned Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.

Omnicare's drug repackaging facility, Heartland Repack Services, distributes drugs through pharmacy services to Omnicare nursing homes, assisted living facilities and other facilities, the warning letter said. During inspections June 27-Aug. 11, 2006, the agency found the drugs were adulterated because of current good manufacturing practice (cGMP) violations with the repackaging system, according to the letter, which was sent Jan. 11 and posted to the FDA website Jan. 30.

Omnicare has begun corrective actions, including recalling all affected products, temporarily closing the facility and hiring outside consultants, the letter said. Omnicare has performed seven recalls since last June, the agency added.

Although Omnicare has begun corrective actions, the FDA said it sent the letter because the corrective actions are not complete, and because of Omnicare's history of cGMP violations noted in inspections in 1996, 1997, 2004 and 2006. Also, the violations are very serious and pose a significant risk to consumers, the FDA added.

The company intends to formally reply to the FDA within the 15 working days the agency requested, company spokesman Andy Brimmer said. Omnicare will also relocate its repackaging operations to a new facility, which will open once the company meets all safety and compliance requirements, he added.

The warning letter can be seen at www.fda.gov/foi/warning_letters/g6208d.pdf (http://www.fda.gov/foi/warning_letters/g6208d.pdf).