Ethex Corporation, a subsidiary of KV Pharmaceutical Company, is issuing a voluntary nationwide recall of prescription prenatal and iron supplements products (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), a company press release stated.
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 (prescription prenatal vitamin) recalled to the wholesale/distributor level are: Advanced NatalCare tablets, Advanced-RF NatalCare tablets, Cal-Nate tablets, CareNatal DHA tablets, ComBgen tablets, ComBiRx tablets, NataCaps capsules, atalCare Gloss tablets, NatalCare PIC tablets, talCare PIC Forte tablets, NatalCare Plus tablets, atalCare Rx tablets, NatalCare Three tablets, NataTab FA tablets, NataTab RX tablets, NutriNate chewable tablets, NutriSpire tablets Prenatal MR 90 FE tablets, Prenatal MTR w/Selinium tablets, Prenatal Rx 1 tablets, Prenatal Z, Advanced Formula tablets, Ultra NatalCare tablets.
The prescription iron supplement products are: Anemagen caplets, Anemagen Forte caplets, Conison capsules, and Fe-Tinic 150 Forte capsules
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 US Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.
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.