Able Labs says bankruptcy a possibility
July 12, 2005
Following the negative inspection from the U.S. Food and Drug Administration, Able Laboratories’ stock plummeted yesterday, reaching a new 52-week low. The generic-drug maker said it might file for bankruptcy protection.
Able has cut about 200 jobs since it announced it was suspending all manufacturing operations and recalled its products due to quality control concerns in May. The FDA concluded the company’s quality-control unit lacks the authority to fully investigate errors, according to the review that is posted on the company’s Web site.
In the review, the FDA said Able’s reports on certain drugs left out reports that may have affected the agency’s conclusions regarding the safety and effectiveness of the drug. In addition, the FDA said Able submitted erroneous data in its drug applications, and the company did not report dispatches of drugs that failed to meet specifications.
The FDA already advised consumers to discontinue use of Able drugs, after discussing changes in treatment options with their doctors first. In all, Able recalled 44 generic drugs, including versions of the painkillers Vicodin, Darvocet, Lortab, Fioricet and Tylenol with codeine, as well as Ritalin and several other drugs.
Able is also the target of shareholder lawsuits, and the company has lost its line of credit and angered vendors with unpaid bills.For more information on the drug recall, please contact us to confer with an attorney.
