Ranitidine Recalls Begin In Europe As Regulators Take Action

OTC products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs.With investigations underway worldwide, regulators across Europe are split into two camps: immediate action or wait and see.

Nitrosodimethylamine
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Germany, Switzerland and Austria are the first European countries to initiate recalls of ranitidine-based drugs after tests showed that certain products contained N-nitrosodimethylamine, a probable human carcinogen.

With a Europe-wide review of ranitidine underway at the European Medicines Agency, national regulators in the DACH region are overseeing company-led recalls of OTC and

The NDMA contamination has been linked by regulators to ranitidine produced by Indian API manufacturer Saraca Laboratories

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