Gabapentin recall

[RobinN]

Last month, Ranbaxy Pharmaceuticals announced a voluntary recall of 73 million tablets of its epilepsy and nerve pain drug, gabapentin, from the US market. The company had to withdraw the product as it was containing certain impurities beyond the permissible levels prescribed by the US FDA. This is the first time an Indian drug company has gone for such a massive recall of a drug from the US market on quality issues.

http://www.pharmabiz.com/article/detnews.asp?articleid=422

Ranbaxy’s voluntary recall of Gabapentin anti-epilepsy tablets is considered as a Class III recall, as per industry sources. As per the US Food and Drug Administration (USFDA), a Class III recall is: “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.” Hence Ranbaxy’s recall may not attract any law suits.

However, the recall of 73 m tablets may result in Rs 4-crore loss as per industry analysts .

http://chemically.wordpress.com/category/litigations-law-suits/
We tried this one too... caused suicidal thoughts
Also discussed here on CWE a while back:
http://www.coping-with-epilepsy.com/forums/f21/generic-neurontin-india-499/
I am so clueless, I assumed I was buying a medicine from the US for my daughter. I didn't even understand it was considered a generic.
Learning quickly...(or not)

 

[Birdbomb]

:hungry: Oh yummy! Just what impurities are they talking about here? Rat turd flavored drugs? Hey isn't that the new hallucinogenic kick?

FDA News

Generic Firm Commences Gabapentin Recall Due to Excessive Impurities
Ranbaxy Pharmaceuticals initiated a voluntary Class III recall of 73 million gabapentin tablets because the allowed level of impurities in the tablets exceeded their specification limits, according to FDA documents.

Gabapentin is the active ingredient in Pfizer’s antiseizure drug Neurontin, which is off patent.

The affected dosage strengths include the 600- and 800-mg tablets. Ranbaxy’s abbreviated new drug application (ANDA) for the tablet formulation is for those two strengths and the firm holds approval for a capsule formulation as well.

The company could not comment on whether the recall will create a shortage of its tablets. Sun Pharmaceutical Industries, Glenmark Pharmaceuticals, Teva Pharmaceuticals, Apotex, Sandoz and Actavis have approved ANDAs for the 600- and 800-mg dosage strengths.