ST. LOUIS, Feb. 3 /PRNewswire/ -- ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale 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).
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, or to obtain replacement medications or prescriptions.
Products Recalled to the Wholesale/Distributor Level:
Prescription Prenatal Vitamin Products:
Advanced NatalCare(R) Tablets Advanced-RF NatalCare(R) Tablets Cal-Nate(TM) Tablets CareNatal(TM) DHA Tablets ComBgen Tablets ComBiRx(TM)Tablets NataCaps Capsules NatalCare Gloss Tablets NatalCare PIC Tablets NatalCare PIC Forte Tablets NatalCare Plus Tablets NatalCare Rx Tablets NatalCare Three Tablets NataTab FA Tablets NataTab RX Tablets NutriNate(R) Chewable Tablets NutriSpire(TM) Tablets Prenatal MR 90 FE Tablets Prenatal MTR w/Selinium Tablets Prenatal Rx 1 Tablets Prenatal Z, Advanced Formula Tablets Ultra NatalCare Tablets
Prescription Iron Supplement Products:
Anemagen Caplets Anemagen Forte Caplets Conison(TM) Capsules Fe-Tinic(TM) 150 Forte Capsules
Any wholesaler 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 email@example.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.
ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products.
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 www.fda.gov/medwatch.
The recall announcement is posted on 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 national leader in generic pharmaceuticals, and Ther-Rx Corporation, its branded drug subsidiary.
|SOURCE ETHEX Corporation|
Copyright©2009 PR Newswire.
All rights reserved