The Chief Pharmaceutical Inspector withdrew one series of a medicinal product called Senna Leaf from the market throughout the country. The reason for the decision is a quality defect. Plastic fragments were found in the tested sample of these infusion herbs.
The Chief Pharmaceutical Inspector announced the withdrawal of a medicinal product called:
Senna leaf (Sennae foliolum), 30 mg ± 5% hydroxyanthracene glycosides calculated as sennoside B in 1 dose (1.1 g of product), herbs for infusion, package size 50 g, GTIN 05909990668458, batch number 1074expiration date 07/2025.
The responsible entity is Zakład Konfekcjonowania Ziół FLOS Elżbieta i Jan Głąb, a general partnership.
GIF banned the marketing of the above-mentioned series of the medicinal product throughout the country.
The GIF made the decision immediately enforceable.
An infusion of senna leaves is indicated for short-term use in constipation.
Reason for the decision
In the justification for the GIF's decision, we read that the expert opinion carried out by the National Institute of Medicines (NIL) as part of the planned inspection of medicinal products on the market showed that the product Senna leaf, batch number 1074, expiration date 07/2025, does not meet the requirements specified in the registration documentation for the parameter “presence mold, living and dead pests and their remains.
Moreover, in the research protocol, NIL included information about “the presence of plastic fragments in the test sample of the above-mentioned drug”.
In a letter sent to the Chief Pharmaceutical Inspector, the responsible entity confirmed the suspicion of a quality defect identified by NIL. At the same time, he indicated that there was a deviation during the manufacturing process of the batch of the drug in question, which resulted in the presence of plastic fragments in the finished medicinal product. The MAH itself recommended withdrawing batch 1074 of the medicine in question from the market.
“In the factual circumstances described above, the Chief Pharmaceutical Inspector found it justified and necessary to withdraw from the market and prohibit the placing on the market of the Senna Leaf medicinal product series,” wrote GIF in the justification of the decision.
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