Generic drugs recalled

Able Laboratories recalled 46 of its medications.

By: Josh Appelbaum
   A Cranbury-based manufacturer of generic prescription drugs issued a recall of its entire line Monday.
   Able Laboratories, located on Able Drive, adjacent to the N.J. Turnpike and off Prospect Plains Road, suspended its manufacturing peration and voluntarily recalled 46 of its medications.
   Representatives from Able declined to comment for the story.
   The recall affects only distributors and pharmacies. The recall still allows patients to continue taking the drugs, although a local pharmacist said the scope of the recall could expand to include drugs already dispensed.
   According to a press release posted on the company’s Web site, the company halted the distribution and dispensing of drugs including generic versions of Ritalin, Tylenol with codeine and lithium, and Vicodin, due to "apparent departures from standard operating procedures with respect to certain laboratory testing practices."
   On May 19, Able Laboratories’ Chairman and Chief Executive Officer Dhananjay G. Wadekar resigned after the company notified the Food and Drug Administration of noncompliance with FDA regulations and improper lab practices in a quarterly report, according to a company press release.
   On Wednesday, Schiffrin & Barroway, a Philadelphia law firm, filed a stockholder lawsuit against the company, which earned $103 million last year, according to its fiscal year 2004 financial report. Able Laboratories’ sales increased 33 percent on the sale of 1.3 billion tablets in 2004, according to the company’s Web site.
   The company has 421 full-time employees.
   Able Laboratories said in a statement on its client hotline that customers taking Able medicines may continue to take them, but that pharmacies and distributors should not dispense the drugs.
   Wayne Diep, a pharmacist at CVS on Abbington Drive in East Windsor, said he received the recall order on Monday and pulled the drugs then.
   Mr. Diep said there are different levels of recalls, but the Able recall did not require his staff to notify customers taking the drugs. He said the recall may have been prompted by improper filing of paperwork by Able to the FDA, but held out the possibility the company would extend the recall.
   "At this point, it just affects pharmacies and distributors," Mr. Diep said. "They could raise the level of the recall and we’d have to notify patients."
   He said the company could have identified a quality issue in one of its drugs or batches, and has not yet identified the specific problem.
   "They might not know which batch is contaminated and decided to pull everything," Mr. Diep said.
   Mr. Diep said most pharmacies have alternate supplies of generic drugs to dispense. He said the recall won’t affect his pharmacy’s ability to fill customers’ prescriptions.
   Mr. Diep said manufacturers of each medicine are identified on the prescription label of each bottle, as per FDA regulation.
   He said customers who feel uncomfortable with taking the recalled drugs are able to return unused portions of their prescriptions in exchange for prescriptions from other manufacturers so long as it meets their insurance specifications and doctors’ orders.
   For information on its products and the product recall, visit Able Laboratories’ Web site at www.ablelabs.com.