Healthplan Spain


Spanish Health Authorities Recall Two Popular Medications Over Safety Fears Health News

The Spanish Agency for Medicines and Health Products (AEMPS), operating under the Ministry of Health, has recently taken swift action by mandating the recall of specific batches of medicines, driven by potential health risks associated with their use.

One of the affected medications is Atropine B. Braun 1 mg/ml, an injectable solution available in 100 ampoules of 1 ml each (NR: 27535, CN: 635649). This particular recall pertains to batch 2112112, whose expiry date is February 29, 2024. Atropine B. Braun is utilised as an adjunct treatment for irritable bowel syndrome, including conditions like irritable bowel, mucosal colitis, and spastic colon.

Similarly, another medication named Scopolamine B. Braun 0.5 mg/ml, also an injectable solution provided in 100 ampoules of 1 ml each (NR: 64566, CN: 608042), has been subjected to withdrawal. The affected batch in this case is numbered 2210212, with a stated expiration date of February 28, 2025. Scopolamine B. Braun finds its application as a premedication for anesthesia, primarily to mitigate excessive salivation and respiratory tract secretions.

The root cause behind these recalls has been identified as a defect in the performance of the sterility test, which fails to meet the criteria set forth by the European Pharmacopoeia. It is noteworthy that both of these drugs are commonly employed within hospital settings.

AEMPS categorises the quality issues into three classes: 1, 2, and 3, with this particular situation falling under class two. Despite being of intermediate severity, the agency emphasizes that these quality defects do not pose a vital risk to patients' well-being.

In response to the recalls, AEMPS has issued directives for the removal of all units from the affected batches that have already been distributed in the market. These units are to be returned to the manufacturing laboratory through established channels. Furthermore, the agency has urged the autonomous communities to actively monitor and participate in the withdrawal process.

Both of the implicated medications, Atropine B. Braun and Scopolamine B. Braun, are products of B. Braun Medical, S.A., a company headquartered in Ronda de los Olivares in Jaén. The actions taken by AEMPS demonstrate a commitment to maintaining the safety and integrity of the pharmaceutical landscape in Spain, underscoring the importance of stringent quality control and consumer protection.