Poland’s Chief Pharmaceutical Inspectorate has ordered an immediate recall of a strong painkiller due to the detection of an unidentified impurity nationwide.
Painkiller Withdrawn from Polish Pharmacies
The Chief Pharmaceutical Inspectorate has decided to immediately withdraw a series of a strong painkiller from circulation throughout Poland. The decision is binding nationwide and has been issued with immediate enforceability.
The recall was prompted by the discovery of an unknown impurity in the product.
Which Medication Has Been Recalled?
The product is a tablet with extended release, packaged in 30 tablets, with GTIN number 05909990743827. The recall applies to a specific series.
Reason for the GIF Decision: Quality Issue
The decision to recall was made after detailed quality tests revealed the presence of an “unknown impurity” in the product.
Was the Painkiller Dangerous to Patients?
Currently, there is no evidence that the detected impurity poses a direct threat to patients. The manufacturer emphasizes that:
Why the Immediate Recall Decision?
The Chief Pharmaceutical Inspectorate stresses that strict quality standards are crucial for medications. If a product does not meet these standards, it cannot remain on the market—even if the risk is not definitively confirmed. Allowing a defective series to remain on the market could expose patients to a product with an unverified safety profile.
What About Patients?
Good news is that, according to national consultants, substitute therapy is possible. In practice, this means the medication can be replaced with another morphine preparation with extended release at the same dosage (10 mg). However, patients should consult with a doctor or pharmacist before changing treatment.
What Should Patients Do Who Are Taking the Recalled Painkiller?
Individuals who have the medication from series H01295 at home should take the following steps:
Standard Procedure for Quality Issues
The decision to recall a drug from the market is a standard procedure when a product does not meet stringent quality standards. It aims to eliminate even the smallest potential risk to patient health.
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