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ABLE LABORATORIES PROBLEMS CONTINUE AS FDA AND QUALITY CARE PRODUCTS LLC ISSUE NATIONWIDE RECALL OF ALL REPACKAGED ABLE DRUG PRODUCTS

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On May 27, the FDA ordered the recall of Abel Laboratories’ entire product line. At the same time, Able suspended all manufacturing, withdrew seven approved applications to market various medications, and saw its Chairman and CEO resign. Able Laboratories Inc., a manufacturer of several generic drugs, also saw the value of its stock plummet by 85%.

Now, in a related move, the FDA and Quality Care Products LLC, a federally licensed drug repackaging company, have notified consumers and healthcare professionals by letter of a recall of all repackaged Able drug products.

Consumers are advised to contact their healthcare providers about replacement products and before discontinuing the use of any of the recalled medications.

Over the past 14 years, Able has had many problems with the FDA including: over 10 drug recalls; charges of selling medications which were either adulterated, mislabeled, or with incorrect potency; failure to report serious adverse reactions with respect to at least five drugs; improper extension of drug expiration dates without proof the drugs would still be effective; and selling drugs with the wrong package insert.

Able has received a number of FDA warnings with respect to these deficiencies and it is unclear what measures the agency will impose with respect to the company’s latest revelations concerning deviations from proper manufacturing practices.

A full list of the recalled products, with identifying tablet imprint codes or liquid formulation lot numbers, is available at: http://www.fda.gov/oc/po/firmrecalls/qualitycare06_05.html. Additional information concerning Able Laboratories can be obtained by calling 1-888-463-6322.

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