Medicines Agency recalls Bosnalijek's Ranibos from the market

(Patria) - The Medicines and Medical Devices Agency of Bosnia and Herzegovina today announced a new statement on the continuation of the procedure for recalling medicines containing the active substance ranitidine manufactured by Saraca Laboratories Ltd. Ranibos, whose marketing authorization holder is Bosnalijek, is also joining the list of medicines recalled from pharmacies in our country. The recall is being carried out down to the pharmacy level and applies to the following batches:

- Ranibos film tablets, 150 mg x 20 film tablets
Batches: 9340, 9341, 9342, 9343, 9344, 9718, 9719, 9728, 9729, 0251, 0252, 6263, 6167, 6168, 6442, 6443, 6444, 6445, 6446, 6447, 6448, 7116, 7117, 7118, 7119, 7120, 7664, 7665, 7666, 7667, 7673, 7674, 7675, 7685, 8244, 8245, 8246, 8247, 8248, 3358, 3359, 3754, 3755, 3756, 3757, 3767, 3768, 3769, 4519, 4520, 4521, 4522, 4984, 4985, 4994, 4995, 4996, 5479, 5480, 3180.

- Ranibos film tablets, 300 mg x 10 film tablets
Batches: 7686, 5486

- Ranibos film tablets, 75 mg x 30 film tablets, batch: 6263.

The aforementioned recall procedure is being carried out based on a suspected quality defect of the active substance ranitidine manufactured by Saraca Laboratories Ltd., related to the presence of a substance called N-nitrosodimethylamine (NDMA), the Agency announced.

Batches of other medicines with the same active substance produced by a different manufacturer are available on the market of Bosnia and Herzegovina, therefore the current recall procedure does not jeopardize the regular supply of the market.