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Is your Augmentin XL (or anything else) by Aurobindo?


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My daughter's pharmacy filled a partial fill of her Augmentin XL with Aurobindo a few days ago. They are based in India and are a company I had never heard of, so of course, I did a search about them. Here is one FDA laundry list of issues spanning from '05 to '11 with no indicator the issues were ever resolved: http://www.fda.gov/iceci/enforcementactions/warningletters/2011/ucm256861.htm.

 

I am sure there are some good companies in India, but kiddo is just now getting back to a "good place" again, and I simply will not take any chances like this. Kiddo had not taken any of the six pills, and I took them back to the pharmacy. They filled all of them in Teva after I took them this article.

 

Please be alert to what generic brands your kids are getting, and use the site I posted to check for FDA warnings against a company you may not be familiar with. Aurobindo's issues are broad in scope and vary in severity, but all are listed in the above article.

Edited by Mayzoo
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Ugh! Thanks for the heads up! A painful reminder that we need to pay attention to what generic manufacturers our pharmacies are using.

 

For some reason your link wasn't working & I had to look it up, let me try reposting it

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm256861.htm

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Well, I'm wondering if they are connected to Dr. Reddy- as I have had scripts filled from them. But, What chafes my hide is that the pharmacies should be well aware of these issues and watching the FDA reports, but continue to do business w/ these companies!

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So, a little more checking and nope, different company. Dr. Reddy is in Mexico. But strange the Aurobindo letter was addressed to a Dr. Reddy..... But, I just checked and Allie's antiviral is from Aurobindo. Sigh, a few months ago I had to return a ranbaxy product....

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Are you using a chain pharmacy or an independent? I agree that it is infuriating that the pharmacies are not doing a better job at screening their drug sources (and these are the &%^$! that tell people not to get their drugs from Mexico or Canada or online because you just can't know what you're really getting).

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I agree pharmacies should be more careful, but my main complaint is that the FDA is clearly aware of these issues and continues to allow these companies to ship into the US. I have no idea how hard it would be to stop these companies, but it seems it would be worth the effort.

 

When I scanned through the letter, yes it is from 2011. It mentions that there have been issues at the '05, '07, '09, '10, and the '11 inspections. It also states that they have apparently falsified their documents even when they did state they resolved issues (pictures later showing plates that they had stated they destroyed). They have also had tests they ran that came out fine, and then soon after the same tests run by the same people in front of the FDA agents show serious problems. Their batch records are incomplete or non-existent.

 

I would not be concerned with one or two old complaints, but this is moderate to serious issues at five different inspections since '05, and evidence that they are not resolving any of the concerns the FDA has. Why the FDA continues to allow them to ship meds in is beyond me. Maybe most or all their meds are fine, but since kiddo just got back to a decently good place and there are so many other generic companies, I am unwilling to take chances with her health.

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