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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Ther-Rx Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level

Contact:
Tammy Butler
Ther-Rx Corporation
877-567-7676

FOR IMMEDIATE RELEASE -- St. Louis, MO, February 3, 2009 – Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company is issuing a voluntary nationwide recall of prescription prenatal and iron supplement nutritionals as 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 medication 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 Level:

Prescription Iron Supplement Products:

Chromagen® Caplet
Chromagen® FA Caplet
Chromagen® Forte Caplet
Encora® Capsule
Niferex® Gold Tablet
Niferex® 150 Forte Capsule
Repliva 21/7® Tablet

Prescription Prenatal Vitamin Products:

PreCare® Chewable Tablet
PreCare® Conceive Tablet
PreCare Premier® Tablet
PremesisRx® Tablet
PrimaCare® Capsule/Tablet
PrimaCare® Advantage™ Capsule/Tablet
PrimaCare® ONE Capsule

Any retail customer inquiries related to this action should be addressed to Ther-Rx Customer Service at 877-567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

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.

Any adverse reactions experienced with the use of these products should also be reported to the 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.;

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