Information on NDMA contamination in ranitidine medicines and recalls

The marketing authorisation holder informed its customers on September 16, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).

The marketing authorisation holder informed its customers on September 13, 2019 that below mentioned batch is recalled because of a incorrect package leaflet.

The marketing authorisation holder informed its customers on August 23, 2019 that below mentioned batch is recalled because the content of the active substance is below specification limits.

The marketing authorisation holder informed its customers on August 1, 2019 that the outer packaging may leak.

The marketing authorisation holder informed its customers on July 3, 2019 that below mentioned batch of „Elotrace - Infusionszusatz“ show black visible particles.

The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market.

"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.

The marketing authorisation holder informed its customers on April 4, 2019 that there is a risk that "Parkemed - Suspension zur oralen Anwendung" will likely contain levels of Lead (Pb) and Lithium (Li) which exceed the Permitted Daily Exposure (PDE) levels.

The marketing authorisation holder informed its customers on March 6, 2019 that the marketing of „Tetraspan 60 mg/ml Infusionslösung“ and „Venofundin 60 mg/ml Infusionslösung“ is ceased permanently for economic reasons.