ETHEX Corporation Issues Voluntary Nationwide Recall
February 03 2009 - 7:27PM
PR Newswire (US)
Previously Issued Recall to Wholesale Level on Certain Products
Expanded to Retail Level ST. LOUIS, Feb. 3 /PRNewswire/ -- ETHEX
Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa;
KVb), is issuing a voluntary expansion to the retail level of a
previously announced recall on certain products. The recall on the
products listed below had previously been issued to the wholesale
level, but is now being expanded to the retail level. The Company
is taking this action as a precautionary measure, because the
products may have been manufactured under conditions that did not
sufficiently comply with current Good Manufacturing Practice
(cGMP). This additional level of recall is to further remove
recalled products from the marketplace. Patients who may have these
products in their possession should continue to take them in
accordance with their prescriptions, as the risk of suddenly
stopping needed medications may place patients at risk. Patients
should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using
these products. Expanded Recall to Retail Level Includes the
Following Products: Morphine Sulfate Extended-Release Tablets 15mg,
30mg & 60mg (All Strengths) Morphine Sulfate Immediate-Release
Tablets 15mg & 30 mg (All Strengths) Dextroamphetamine Sulfate
Tablets 5mg & 10mg (All Strengths) Isosorbide Mononitrate
Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)
Any retail customer inquiries related to this action should be
addressed to ETHEX Customer Service at 1-800-748-1472, faxed to
ETHEX Customer Service at 314-646-3788, or e-mailed to .
Representatives are available Monday through Friday, 8 am to 5 pm
CST. This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration (FDA). At this time, the Company is
unable to determine when distribution of these products will
resume. Patients with questions about the recall should call the
telephone number above, or contact their healthcare providers. Any
adverse reactions experienced with the use of these products should
also be reported to FDA's MedWatch Program by phone at
1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA,
5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch
website at http://www.fda.gov/medwatch The recall announcement is
posted on http://www.kvpharmaceutical.com/. About KV Pharmaceutical
Company KV Pharmaceutical Company is a fully integrated specialty
pharmaceutical company that develops, manufactures, markets, and
acquires technology-distinguished branded and generic/non-branded
prescription pharmaceutical products. The Company markets its
technology distinguished products through ETHEX Corporation, a
nationwide leader in generic pharmaceuticals and Ther-Rx
Corporation, its branded drug subsidiary. DATASOURCE: ETHEX
Corporation CONTACT: Ann McBride, 1-800-748-1472, for ETHEX
Corporation Web Site: http://www.kvpharmaceutical.com/
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