For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser Investigation Underway, Generic Zantac Shipments Stopped. Recall Next? Almost Undoubtedly
Sep
25

Investigation Underway, Generic Zantac Shipments Stopped. Recall Next? Almost Undoubtedly

Bloomberg News recently published a lengthy piece on how carcinogens are allegedly infiltrating the generic drug supply in the United States. The very next day, drug safety officials announced that they were investigating whether Zantac and its generic counterparts contain levels of the probable carcinogen N-Nitrosodimethylamine, or NDMA – the same chemical that was found in blood-pressure pills last year. Those pills were ultimately recalled, and those recalls are still expanding as we saw this week with Torrent Pharmaceuticals Ltd. Now Sanofi, having confirmed the presence of NDMA, has started to recall generic Zantac.

Now the same show is on replay.

Here are some of the key facts repeated in all the coverage, along with between-the-lines lessons manufacturers should be taking away from how this story is playing out:

  • NDMA, the alleged contaminant, is a likely human carcinogen found in cooked or cured meats such as bacon. It’s also an industrial byproduct. Most importantly for today’s manufacturers, it was the culprit causing blood-pressure medications – versions of valsartan – to be recalled last year. This set a precedent that NDMA is considered a dangerous contaminant worth of market and consumer level action.
  • The ongoing investigation is focused on ranitidine, the generic form of Zantac. While all the headlines are focused on Zantac, it is just one of many products that could be impacted. Just because you’re not Sanofi, doesn’t mean you’re safe from regulatory scrutiny.
  • Many of the products under investigation were made in China or India. As many outlets are noting, this fact is raising questions about the quality of overseas manufacturing facilities and producers. FDA’s first target in shoring up the manufacturing supply chain for US drugs is those directly involved in this ranitidine matter. But any company with international production facilities, especially in China or India, should be prepared for regulators knocking on your door. Evaluate your supply chain management efforts and take action if you have any concerns about their ability to comply with applicable regulations.
  • Sanofi acted quickly by halting shipments, then recalling generic Zantac after confirming the presence of NDMA. So while health safety officials haven’t yet directed individuals to stop taking ranitidine all together, we can all see where this was going. More recalls are imminent.

Our experience tells us we’re far from the end of this story. More products and more companies will be impacted – whether they produce ranitidine or simply work with an overseas manufacturing facility. The real question: Are you are ready?

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