Ther-Rx Corporation Issues Voluntary Nationwide Recall of Prescription Prenatal and Iron Supplements to Wholesale Level
February 03 2009 - 7:29PM
PR Newswire (US)
ST. LOUIS, Feb. 3 /PRNewswire/ -- Ther-Rx Corporation, a subsidiary
of KV Pharmaceutical Company (NYSE:KVa/KVb), 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(R) Caplet
Chromagen(R) FA Caplet Chromagen(R) Forte Caplet Encora(R) Capsule
Niferex(R) Gold Tablet Niferex(R) 150 Forte Capsule Repliva 21/7(R)
Tablet Prescription Prenatal Vitamin Products: PreCare(R) Chewable
Tablet PreCare(R) Conceive Tablet PreCare Premier(R) Tablet
PremesisRx(R) Tablet PrimaCare(R) Capsule/Tablet PrimaCare(R)
Advantage(TM) PrimaCare(R) ONE Capsule Capsule/Tablet 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 .
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 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
national leader in generic pharmaceuticals, and Ther-Rx
Corporation, its branded drug subsidiary. DATASOURCE: Ther-Rx
Corporation CONTACT: Tammy Butler, 1-877-567-7676, for Ther-Rx
Corporation Web Site: http://www.kvpharmaceutical.com/
Copyright