Popular children's painkiller halted from marketing. Check batch numbers
Published March 11, 2024 09:39
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The Chief Pharmaceutical Inspector has decided to suspend nationwide marketing of the medicinal product named Paracetamol Aflofarm (Paracetamolum) oral suspension, 120 mg/5 ml, 1 bottle 100 ml GTIN 05909991076115 for the following series:
Lot number: 04AF0622, expiration date: 30.06.2025
Lot number: 01AF1122, expiration date: 30.11.2025
Lot number: 01AF1022, expiration date: 31.10.2025
Lot number: 02AF1022, expiration date: 31.10.2025
Lot number: 01AF0222, expiration date: 28.02.2025
The responsible entity is Aflofarm Farmacja Polska Sp. z o.o., based in Pabianice
The Main Pharmaceutical Inspectorate received a notification from the manager of one pharmaceutical wholesaler regarding a suspected failure to meet quality requirements. The reason for the notification was the identified precipitate at the bottom of the bottles in the wholesaler's stock, which, despite vigorous shaking, did not homogenize so as to form a homogeneous suspension.
The Chief Pharmaceutical Inspector found that in order to protect the health and lives of patients who might accept a medicinal product that did not meet the quality requirements, it was reasonable and necessary to give this decision the order of immediate enforceability - based on Article 108 § 1 of the Code of Administrative Procedure. The decision in question is of a precautionary nature and serves to stop the marketing of a medicinal product whose quality is reasonably suspected, for the duration of further investigation by the Chief Pharmaceutical Inspector.
Source: GIF
