One of the batches is Pantoprazol Zentiva, a gastroresistant tablet, and the other is Pantoprazol Hikma, a powder for injectable solution, according to two informational circulars published on Infarmed's website. “The company Zentiva Portugal Lda., will proceed with the voluntary collection of batch no. AR0528, with validity 06/2023, of the drug Pantoprazol Zentiva, Pantoprazol 40 mg, gastroresistant tablet, with the registration number 5101019, as it was detected, during a stability study, an out-of-specification result for the dissolution parameter”, adds the medicine's authority.
The warning about the batch of the drug Pantoprazole Hikma, 40 mg, 2010174.1, valid 12/2022, comes after the marketing authorization holder (MA), Hikma Farmacêutica (Portugal), is proceeding with the collection of the affected batch of this drug. The drug is being withdrawn "following a quality defect related to the existence of a bottle labeled "Acyclovir Hikma 250 mg" in the secondary packaging of the drug Pantoprazole Hikma, 40 mg, powder for solution for injection”, says Infarmed.
The medicine authority calls on entities that have these batches of medicine in 'stock' not to sell, dispense or administer them, and must return them. Infarmed is also intended for patients who are using medicines belonging to this batch so as not to interrupt the treatment and so that, “as soon as possible”, they contact the doctor to replace it with another batch or alternative drug.