On August 11, the Spanish Medicines Agency (AEMPS) ordered the withdrawal of several batches of two injectable drugs, the Atropina B. Braun and the Scopolamine B. Braun. According to the alert issued, the “sterility test” of these batches “does not meet the requirements established in the European Pharmacopoeia.”
These drugs are manufactured in the laboratorio B. Braun Medical, S.A.found in Jaen and are marketed in Spain. Atropine is often prescribed for patients with irritable bowel syndrome, and scopolamine is used to reduce excessive salivation before anesthesia.
The batch of Atropine B. Braun, in presentation of 1 mg/ml in 100 ampoules of 1 ml, that must be withdrawn is the one corresponding to the 2112112, with expiration date 02/29/2024. And that of Scopolamine B. Braun, also in injectable presentation with 100 ampoules of 1 ml, would be the batch 2210212with expiration date 02/28/2025.
The agency has informed that they do not pose a serious risk to health but that it requests their withdrawal to avoid possible side effects in the patients. Now the communities will be in charge of carrying out this withdrawal.