posted
I received this information from someone who wishes to remain anonymous but asked me to post it here:
<< The FDA searched the NJ US headquarters of Ranbaxy Pharmaceuticals on Wednesday. It is probably a follow up to FDA's June warning letter to Ranbaxy. This could mean that the FDA will start seizing or recalling Ranbaxy product; unfortunately, the product that is already in the pipeline may already be in patient hands and may not be traceable.
Ranbaxy manufactures a number of antimicrobials, including a generic version of cefuroxime axetil (Ceftin). >>
-------------------- Suzanne Shaps STAND UP FOR LYME Texas (www.standupforlyme.org) (Please email all correspondence related to protecting Texas LLMDs to [email protected] with copy to [email protected]) Posts: 977 | From Austin, TX, USA | Registered: May 2004
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posted
Yikes, I take this drug. Does anyone know why it is being recalled? Cindy
-------------------- Cindy Posts: 227 | From VA | Registered: Sep 2005
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Cobweb
Unregistered
posted
usually with a recall there's a statement about what the company is suggesting the consumer do about it-and what to look out for in terms of negative impact. Anymore info ???
Hay or is that Hey- maybe I'll get rich in a class action lawsuit because I've been taking generic Ceftin for 9 months ! Maybe that's why I feel like this
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They make a lot of generics. We don't know which ones are affected or why the FDA is involved. And there is probably more than one maker of such generics, so you people who are on ceftin should not automatically assume you got stuff made by these people and that it was bad.
I posted this info earlier, it was in the news, nothing confidential here. What we really need to know is why this is going on. Stay tuned, I guess.
Posts: 8430 | From Not available | Registered: Oct 2000
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posted
The email does not say that there is a product recall. Is there any way to change the subject line so that it accurately reflects the safety concerns?
Also, Lou is right. Ceftin has been generic for several years, so there are multiple FDA approved generic manufacturers. My pharmacy stocks another generic brand of cefuroxime axetil (the generic form of Ceftin).
Posts: 183 | From US | Registered: Feb 2004
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posted
Here is some more info which I am receiving from a reliable source. I do not know any more than what I am posting. If you have questions, please contact your health care provider.
Princeton, New Jersey - February 15, 2007 -- Ranbaxy Inc., said today that federal officials conducted a search at its New Jersey offices on Feb 14, 2007.
Ranbaxy said that this action has come as a surprise. The company is not aware of any wrongdoing. It is co-operating fully with the officials.
Meanwhile, the company's operations continue as normal.
Ranbaxy Product list-NOTE: They also received FDA approval on Feb.7 for several dosage formulations of setraline (Paxil)
Ranbaxy Laboratories Limited entered the US generic pharmaceutical market in 1994 with the filing of five ANDAs for Cefaclor and, upon approval from the US FDA in 1997, introduced the product under its own label, Ranbaxy Pharmaceuticals Inc. (RPI), in January 1998.
Since then, RPI's generic line has experienced successful and dramatic growth every year. Today, RPI focuses on submitting 20+ ANDAs every year with an average approval cycle of 12 months.
This phenomenal growth is due, in part, to backward integration. Simply put, this means that RPI has total control of many of its products, by performing every step in the process from producing the active ingredient, to processing, manufacturing, and delivering the finished dosage form. This backward integration results in a greatly streamlined and efficient process.
RPI is proud of its popular anti-infective products, and also produces quality anti-expectorants, gastrointestinal products, cardiovasculars, NSAIDs, analgesics, and CNS products. Generic products are manufactured as capsules, tablets and suspensions, and are manufactured at FDA approved plants. Our products are sold through various chains, wholesalers, generic distributors and hospitals.
With 47 products and over 186 SKUs, RPI is poised for future growth and success with its generic pharmaceuticals line. Check back with this site as our generics line continues to expand and develop.
Safety concern:
Even if the physician writes DAW for a specific generic brand, it is becoming extremely difficult for the physician to ensure that their patient receives dispenses of the generic brand that they are writing the prescription for. Given that Ranbaxy has had documented manufacturing issues with BOTH the FDA and World Health Organization, and given the variation in binders, fillers and coatings between different generic brands, and the fact that these generic drug differences may cause differences in drug metabolism and/or absorption, and may cause issues with insulin control for diabetics, this is a growing safety concern.
From:
Sent: Wednesday, January 17, 2007 10:22 AM To: Subject:
To: ,
From:
Thank you for taking the time to speak with me.
As we talked about, there are a large number of prescription drugs that have recently gone off patent, and popular drugs such as Ambien are scheduled to go off patent in 2007. It concerns us that the increased volume of prescription drugs and the increased number of generic vendors will precipitate stockpiling of brand and generic counterparts, delete.
Delete In addition, we are concerned that increased drug inventory volumes from generic drugs may also cause additional FDA oversight and compliance gaps beyond those mentioned in your report entitled Prescription for Harm . This may lead to greater numbers unsafe dispenses. Of particular note is the FDA's lack of day to day oversight of Indian manufactured generic drug components and/or finished products. Given that there are no FDA offices in India, and weak oversight on the part of Indian oversight agencies, delete name also has concerns about the FDA's ability to promptly and adequately respond to potential or current Indian drug manufacturing and oversight issues. Please refer to the attached FDA Warning letter to Ranbaxy Pharmaceuticals and the embedded Ranbaxy product and price list for more information
-------------------- Suzanne Shaps STAND UP FOR LYME Texas (www.standupforlyme.org) (Please email all correspondence related to protecting Texas LLMDs to [email protected] with copy to [email protected]) Posts: 977 | From Austin, TX, USA | Registered: May 2004
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