QUALITY CONTROL PROBLEMS FORCE ABLE LABORATORIES TO RECALL ENTIRE DRUG LINE AND TO SUSPEND ALL PRODUCTIONMay 28, 2005 | www.Newsinferno.com It is not unusual for a pharmaceutical manufacturer to have an occasional problem with testing practices or quality control. When this occurs, the typical solution is to recall one or two drugs or to close down the offending plant until the deficiencies are corrected. This happened in March of this year when Glaxo-SmithKline was ordered to halt temporarily the distribution of Paxil CR and Avandamet as a result of failing to meet federal production standards. Glaxo’s plant in Cidra, Puerto Rico was temporarily closed in order to correct the problems.
It is highly unusual, however, for a pharmaceutical company to recall its entire product line, suspend all manufacturing, withdraw seven approved applications to market various medications, and have its Chairman and CEO resign all at the same time. That, however, is precisely what has occurred at Able Laboratories Inc., a manufacturer of several generic drugs. With no products to sell and no manufacturing being done, the value of Able’s stock plummeted 85%.
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 drugs can be found at www.fda.gov and consumers may obtain addition information concerning Able Laboratories by calling 1-888-463-6322. .
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