The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal from the market of all units of four batches of the antibiotic drug Levofloxacin Mabo-Farma 500 milligrams manufactured by indian company Torrent Pharmaceuticals Limited (TPL) in EFG film-coated tablets in its presentations of seven and 14 tablets after detecting an impurity “above the established limits.”
This was specified in a statement in which he pointed out that it is a quality defect that “does not pose a life-threatening risk to the patient”.
Specifically, the affected lots of seven tablets They are CB33J003, with an expiration date of November 30, 2025, and CB33K005, with an expiration date of April 30, 2026.
In the case of container of 14 tabletsthose affected are batch CB33J004, with expiration on November 30, 2025, and CB33K004, with expiration on April 30, 2026.
As a precautionary measure, it has been ordered recall of all units distributed from the affected batches and their return to the laboratory through the usual channels.