Ther-Rx Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level
Date of Recall
2009-02-03Recall Details
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 [email protected]. 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.;
Recall Comments
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