FOR IMMEDIATE RELEASE -- 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
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.;
http://www.fda.gov/oc/po/firmrecalls/therrx02_09.html
Ther-Rx Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level
Contact:
Tammy Butler
Ther-Rx Corporation
877-567-7676
FOR IMMEDIATE RELEASE -- 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.;
[此贴子已经被作者于2009-2-7 13:36:14编辑过]
prima care one with dha & epa 被recall了是不是?
我们楼里面好几个mm都在吃这个尼~~~
好在我的药定了还没来，赶紧CANCEL 去~~~
现在是怎么办？吃之前OB给开的PRECARE PREMIER？ 同一个公司出的会不会也有问题？
JM们又什么好的PRENATAL VITAMIN建议？
既然说是因为潜在的生产环境不符合GMP，希望是最近才有的，不是很长期的问题啦～～
我也是,一直吃到娃3个多月.
现在刚怀上老二, 还没有看ob.我已经自己先吃了一段时间,不知道有没有什么 问题啊?
[此贴子已经被作者于2009-2-8 23:22:25编辑过]
我怀孕的时候一直吃的这个。现在宝宝都生出来了，怎么办啊？对宝宝会不会有什么不好的影响啊？
same here
我一直吃，宝宝都15个月了
我大宝都要24个月了。基本都在吃. 希望没有什么影响
我也是吃它. 还挺贵
网上说:Patients who may have these products in their possession should continue to take them in accordance with their prescriptions. 谁还敢吃呀. 没开封的能退吗?
是呀，恨死我了，我刚买了3瓶，郁闷！
我一直吃，宝宝都15个月了
same here!!!!!!!!!
我的OB告诉我没事，可以继续吃，不是质量问题，据说新生产的会增加DHA的含量。打电话给pharmacy也说可以继续服用。