Poland’s GIF pharmaceutical inspectorate has ordered an immediate nationwide recall of the Dolofest pain relief patch due to a critical packaging flaw.
Warning from GIF: Pain Relief and Anti-inflammatory Drug Withdrawn From Pharmacies
The Main Pharmaceutical Inspectorate (GIF) has issued a strict decision to immediately halt the distribution of a pain relief and anti-inflammatory drug throughout the country. The reason? Quality control tests revealed a “critical defect” in the packaging that could directly affect the effectiveness and safety of treatment. Patients should not use existing products until the matter is clarified.
Check the batch numbers and find out exactly what the National Institute of Drugs detected.
Why is the Pain Relief Drug Disappearing From Pharmacies?
GIF decided to withdraw the drug from the market after receiving the results of quality tests conducted by the National Institute of Drugs. These tests showed a discrepancy in one of the key quality parameters – the tightness of the sachet in which the product is packaged.
Dolofest: Product Details
Dolofest is a product in the form of topical pain relief patches. Solinea sp. z o.o. is responsible for its introduction to the market.
Packaging Defect: NIL Experts Warn of Leakage
Testing of a sample from one batch of the drug showed an out-of-specification (OOS) result, indicating potential packaging leakage. Experts say this could mean a risk of product instability during storage, which in turn could affect its quality and therapeutic efficacy. GIF emphasized that:
“Threat to Health”: Immediate Enforcement is No Accident
GIF has given the decision immediate enforceability, meaning the drug must be withdrawn from distribution immediately. The reason is to protect patient health – the authority indicated that even the potential risk of reduced quality of the medicinal product in this category requires preventive action.
What to Do With the Withdrawn Drug? Instructions for Patients and Pharmacists
Individuals possessing Dolofest should refrain from use.
Details of Batches Covered by the GIF Decision
Information regarding specific batch numbers subject to the GIF decision is available.
Can Withdrawn Batches Return to Pharmacies? The Manufacturer Has the Right to Appeal
The decision is not final. The manufacturer has the right to request a reconsideration of the case. However, this does not suspend the execution of the decision.
Copyrighted material – all rights reserved. Further distribution of the article with the publisher’s consent INFOR PL S.A. Purchase a license.
Enter the email address of the selected person, and we will send them free access to this article.
Related
Copyright © INFOR PL S.A.
