Suspected human hair in tablet cited in FDA's Ranbaxy import ban (Leading Indian Drugmaker)

[OhioChick]

Source: Reuters

Sept 18 | Wed Sep 18, 2013 6:07am EDT

(Reuters) - During a visit to a facility of leading Indian drugmaker Ranbaxy Laboratories Ltd last year, U.S. inspectors found that a black fibre embedded in a tablet may have been a hair from an employee's arm, according to documents seen by Reuters.

That and other quality concerns led the U.S. Food and Drug Administration to impose an "import alert" on its Mohali plant last week, saying the factory owned by India's biggest drugmaker by sales had not ensured manufacturing quality.

Ranbaxy, which is 63.5 percent-owned by Japan's Daiichi Sankyo Co and gets more than 40 percent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.

The FDA's action has dealt another blow to an Indian generic drug industry battered by a rash of American regulatory rebukes and as U.S. demand for generics grows, especially under President Barack Obama's new healthcare programme.

Read more: http://www.reuters.com/article/2013/09/18/india-ranbaxy-fda-idUSL3N0HE16P20130918

[jberryhill]

2. Indeed, it may have been the most pharmacologically active component

[hog]

3. arm hair

Our government meat inspectors allow "chunks" of fecal matter in our pork. Why should we be offended by an arm hair in a pill?

[Thor_MN]

4. I first thought this was about tablet device... Hair on my touch screen, big deal...

But in a pill? Eye of Newt and Toe of frog... Eew.

[grilled onions]

5. I Find Their Lack Of Quality A Bitter Pill To Swallow

There are days when I feel my pills are more filler than med so you got to wonder some times if there isn't a slight of hand going on with some batches of pills. A little more filler can sure go a long way to help pay for fines on former lapses of quality!

[dixiegrrrrl]

6. One of my generic meds, from India, appears to have no meds in it

One of my meds is made by Lupin, genric drug maker, which is in India.
Very good med, fast and effective, I take it daily.
Last re-fill, it came in different container, different size and color, so I checked it out, it was from a different company, again in India, Wiki tells me.
Took it for 3 days, it had NO effect whatever.
Called my doc, who called a new script into a different pharmacy which had the Lupin brand meds.
They worked, I could tell, within 20 minutes of taking it.

good news is the script only cost 10.00 for a 90 day supply.
Pharmacies will not accept return of opened meds, I don't blame them.

Lesson learned..I made a list of all of our meds, including maker, for future reference.

[Skittles]

7. gross