THE EPO proceed with the withdrawal of lot 25LFC070 with expiry date 12/2030 of the product «Cotton Hydrophile 1kg» by Xinghua Xingxin Medical Co Ltd, China.
The results of the laboratory tests carried out by the Agency's Laboratory Directorate on cotton in question do not comply with the European Pharmacopoeia specifications, both in terms of appearance and absorption, i.e. the water absorption capacity.
VIOLAK INTERNATIONAL AE, as an importer and distributor of the product on the Greek market, is required to contact the recipients of the product directly in order to withdraw the consignment concerned from the market.
At the same time, the relevant documents of the withdrawal should be kept for at least five years and made available to the IF if requested.
EOF: The decision
The withdrawal of the lot 25LFC070 with an expiry date of 12/2030 of the product Cotton hydrophile 1kg of Xinghua Xingxin Medical Co Ltd, China, because the results of laboratory tests carried out by the EOF Laboratory Directorate do not comply with the European Pharmacopoeia’s specifications for the control of the appearance and control of absorption (water absorption capacity).
VIOLAK INTERNATIONAL AE as importer/distributor of the product on the Greek market should contact the recipients of the product immediately in order to withdraw the lot from the market. The relevant documentation must be kept for at least five (5) years and put to the attention of the IF, if requested.
source: Iatropedia.gr
