Popular laxative herbs withdrawn from market
Published Jan. 8, 2025 10:38
On the basis of an expert opinion carried out by the National Institute of Medicine, the Chief Pharmaceutical Inspector has decided to withdraw from marketing nationwide a series of the medicinal product Senesa leaf (Sennae foliolum) 30 mg ± 5% of hydroxyanthracene glycosides calculated as sennoside B in1dose (1.1g of the product), herbs for brewing, package size 50 g, GTIN 05909990668458. The decision concerns series number 1074 with expiration date 07.2025. The entity responsible for the product is Zakład Konfekcjonowania Zół FLOS Elżbieta i Jan Głąb spółka jawna.
Reason for withdrawal
NIL's expert report showed the presence of plastic fragments in the drug sample tested. According to Test Protocol No. NI-0583-24, dated December 19, 2024, the product does not meet the requirements specified in the registration dossier for the parameter "presence of mold, live and dead pests and their residues."
The responsible party confirmed the presence of a quality defect, pointing to a deviation in the production process that led to product contamination. As a result, it itself recommended the recall of batch number 1074.
Product information
Senesa leaf for brewing is used as a laxative.
Source: GIF
