ST LOUIS (MD Consult) - ETHEX Corporation, a subsidiary of KV Pharmaceutical Company, has issued a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale level.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA). At this time, ETHEX can't determine when distribution of these products will resume.

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 possess these products should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place them at risk. Patients should contact their physician or health care provider to obtain replacement medications or prescriptions or if they have experienced any problems that may be related to using these products.

Products recalled to the wholesale/distributor level include the following:

Prescription prenatal vitamin products:

• Advanced NatalCare Tablets;
• Advanced-RF NatalCare Tablets;
• Cal-Nate Tablets;
• CareNatal DHA Tablets;
• ComBgen Tablets;
• ComBiRx Tablets;
• NataCaps Capsules;
• NatalCare Gloss Tablets;
• NatalCare PIC Tablets;
• NatalCare PIC Forte Tablets;
• NatalCare Plus Tablets;
• NatalCare 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; and
• Ultra NatalCare Tablets.

Prescription iron supplement products:

• Anemagen Caplets;
• Anemagen Forte Caplets;
• Conison Capsules; and
• Fe-Tinic 150 Forte Capsules.

Any wholesaler inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 AM to 5 PM CST.

ETHEX 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. Any adverse reactions experienced using 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 Web site at www.fda.gov/medwatch.

The recall announcement is posted on www.kvpharmaceutical.com.
 

圣路易斯 (MD Consult)——KV制药公司的子公司之一ETHEX公司日前发布了一个美国全国范围内的自愿召回令，向批发商召回下列产品（所有批次都在药物有效期内）。

该召回通知了FDA。在发出召回时，ETHEX还不能确认何时再次销售。

ETHEX公司之所以发布上述召回令作为防范措施，原因在于这些产品可能是在不完全符合当前药品生产质量管理规范（cGMP）的条件下生产的。

可能拥有这些产品的患者应继续按处方单使用它们，原因在于突然停用必需药物可能会带来危险。如果出现可能与使用上述产品相关的任何问题，或者为寻求替代药物或其他治疗方法，患者都应与其经治医师或医护人员取得联系。

召回产品名单如下：

产前用处方维生素：

• Advanced NatalCare片；
• Advanced-RF NatalCare片；
• Cal-Nate片；
• CareNatal DHA片；
• ComBgen片；
• ComBiRx片；
• NataCaps胶囊；
• NatalCare Gloss片；
• NatalCare PIC片；
• NatalCare PIC Forte片；
• NatalCare Plus片；
• NatalCare Rx片；
• NatalCare Three片；
• NataTab FA片；
• NataTab RX片；
• NutriNate Chewable片；
• NutriSpire片；
• Prenatal MR 90 FE片；
• Prenatal MTR w/Selinium片；
• Prenatal Rx 1片；
• Prenatal Z, Advanced Formula片；
• Ultra NatalCare片。
处方铁补充剂：
• Anemagen囊片；
• Anemagen Forte囊片；
• Conison胶囊；
• Fe-Tinic 150 Forte胶囊。

批发商对上述召回令若有任何质询，请拨打ETHEX公司客户服务电话1-800-748-1472，或传真至314-646-3788，或发送email至  ，受理时间为美国中部时间(CST)周一至周五8 AM～5 PM。

ETHEX公司已经开始将召回令发给美国全国有上述召回产品库存的批发商，要求其返还召回产品。

对上述召回令有疑问的患者应打上述电话咨询或联系医护人员。使用上述产品期间发生任何不良反应都应报告给FDA的MedWatch Program，电话请拨1-800-FDA-1088，传真请拨1-800-FDA-0178，信件请寄至MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787，或者登陆MedWatch网站：www.fda.gov/medwatch。

召回声明请参阅下列网址：www.kvpharmaceutical.com

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