For the third time in four months, Lupin Pharmaceuticals, one of India’s biggest suppliers of generic drugs to foreign markets, has been admonished by the Food and Drug Administration for a series of troubling quality-control issues at a manufacturing facility.
In a recent inspection report, the regulator cited the company for failing to thoroughly review unexplained deficiencies in batches of medicines and not taking “scientifically sound” steps to evaluate samples; delays in assessing health hazards; insufficiently investigating customer complaints, including an instance involving mold on medicines shipped to the U.S.; and a lack of oversight and training.
As an example, Lupin received nearly 60 complaints going back as far as 2011 that certain tablets had “blackish, greyish spots” and the company claimed this was caused by oil that was mixed with the product, causing lumps or black spots. Yet none of the subsequent investigations offered evidence to support the contention, a hazard assessment was not run until last month,and it was inconclusive.
Hi, I had a heart attack on Labor Day 9/2/2019 and feel it is the fault of this Lupin Lovistatin I began taking on 5/26/2019, after 4 years taking a different brand Teva with no problems. My yearly checkup Jan 2019 with my Cardiologist had me a 120/80 BP with over 95% hear function after 4 years since my first heart attack May of 2015. The Giant Eagle Pharmacy told me Lupin was replacing the 20mg Teva brand when I got my refill 5/26/2019. After about a month I noticed discomfort in my chest, questioned the change of brands, found out there was a recall of 40mg Lovi’s from Lupin in Feb 2019 which the pharmacy said they were aware of but the 20mg weren’t effected so I continued taking & the discomfort continued so i requested my next refill on 8/26/2019 be Teva 10mg, 2 a day which i got but the damage was done & by 9/2 I was code purple in the ER, 100% blockage of the Widowmaker & 95% of the main right artery. I know its the Lupin. Now I’m screwed, on a longer road to recovery & may never have as good a functioning heart again. If you know of anything I could do along with more info on Lupin please let me know. I live in Lorain Ohio & Thank God for the staff at Mercy Hospital for saving my life but any help in direction & support from you would be appreciated. Thanks John Jannuzzi (440)949-0352 Please send me this email back so I have a record of it also….cool
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