Ther-Rx Corporation Recalls Prescription Drugs
Ther-Rx Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).
One of the products, Gynazole-1, was also distributed internationally to Eastern Europe, South America, Asia, and Canada.
Patients who may have these medicines 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 WHOLESALE Level:
Gynazole-1, NDC 64011-0001-08
Clindesse, NDC 64011-0124-08
microK Extencaps 8mEq 100, NDC 64011-0010-04
microK Extencaps 8mEq UD, NDC 64011-0010-11
microK Extencaps 8mEq 500, NDC 64011-0010-08
microK Extencaps 10mEq 100, NDC 64011-0009-04
microK Extencaps 10mEq UD, NDC 64011-0009-11
microK Extencaps 10mEq 500, NDC 64011-0009-08
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 health care providers.