What Goes into an FDA Recall?
This Briefing is brought to you by AHLA’s Life Sciences Practice Group.
- August 10, 2022
- Lee Rosebush , BakerHostetler
- Marc Wagner , BakerHostetler
- Frank Palumbo , BakerHostetler
In 2019, the Food and Drug Administration (FDA) became aware that ranitidine, a popular over-the-counter drug (Zantac) used to treat stomach problems, contained N-Nitrosodimethylamine (NDMA). NDMA is a human carcinogen that grows to dangerous levels when stored at higher than room temperature. While the FDA did not observe unacceptable levels of NDMA in the samples, it could not be sure that the drug was properly stored. Consequently, FDA issued a press release requesting manufacturers to withdraw ranitidine and advised consumers to stop taking any ranitidine immediately. Several drug manufacturers proceeded to recall ranitidine products as well.
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