Third brand of ranitidine-based medication recalled in Greece

Third brand of ranitidine-based medication recalled in Greece

Following the recalls of the ranitidine-based heartburn drugs Zantac and Lumaren earlier this week, Greece's National Organisation for Medicines (EOF) on Friday also announced the voluntary recall of batches of the drug PTINOLIN inj. sol. 50mg/2amp.

An EOF announcement said the decision was reached to "reinforce the voluntary recall made by the company HELP ABEE after the certificate of suitablity of the supplier Saraca Laboratories Ltd for the active ingredient ranitidine was revoked."

The recall concerns batches 64107 with the expiration date 04/2020, 64157 with the expiration date 04/2020, 64167 with the expiration date 11/2020, 64177 with the expiration date 11/2020 and 64187 with the expiration date 11/2020.

As holder of the license to distribute the product, HELP ABEE is obliged to complete the recall "within a reasonable space of time," the announcement said.

Greek authorities, following the lead of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), this week proceeded to recall brand-name and generic versions of popular heartburn medications over fears that production lines have been contaminated with the potential carcinogen N-nitrosodimethylamine, or NDMA.

The drug was sold as both over-the-counter and prescription medication, in pill and injectable form.


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