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by refurb 2357 days ago
From what I’ve read (the FDA website is fantastic), it’s an issue, but not a huge one.

Valisure said “these levels are too high”, the FDA came back with “you’re testing it wrong”, so the FDA retested and determined a few of the drugs has higher than allowed NDMA, but we’re talking 10-50% too high (of a very small limit), not the 20,000% too high that Valisure claimed.

My guess is the FDA will institute new guidelines on testing, manufacturers will change their processes and ranitidine will come back in a year or so.

1 comments

nitrosamines are nasty stuff in general. I would not be surprised this ends up in revision of safe levels.