UPDATE: The FDA announced a Consent Decree of permanent injunction
enjoining KV Pharmaceutical Company, its subsidiaries Ethex
Corporation and Ther-Rx Corporation, and its principal officers. The
injunction will prevent the companies from manufacturing and shipping
drugs until the firm obtains FDA approval.
The generic drug company Ethex Corporation is expanding earlier
recalls to now include over 60 generic drug products(Morphine),
including narcotics and cardiac medications, as well as several dozen
prescription prenatal vitamins and iron supplements. The company is
taking this action as a precautionary measure because these products
may have been manufactured under conditions that didn't comply with
current Good Manufacturing Practices. Certain lots of some of these
products were recalled earlier because of defects such as oversized
tablets.
The additional products are being removed to assure that no other
defective products remain in the marketplace. Most of them are
recalled at the wholesale level, while a few are recalled to the
retail pharmacy level. The complete list of affected products can be
found below.
Patients who may have these products should continue to take them
according to their prescriptions, because if they suddenly stop taking
needed medication, it may put them at risk. Patients should contact
their healthcare provider if they experience any problems that may be
related to these products, or, if necessary, to obtain replacement
prescriptions. For more information contact Ethex Customer Service at
1-800-748-1472.
Additional Information:
FDA Press Release. FDA Takes Action Against KV Pharmaceutical Company.
March 2, 2009.
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01965.html
FDA MedWatch Safety Alert. Ethex Corporation Product Recall. February 4, 2009.
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex
KV Pharma Press Release. ETHEX Corporation Issues Nationwide Voluntary
Recall of Products. January 28, 2009.
http://www.ethex.com/news/pressRelease012809.aspx
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