Poland’s Chief Pharmaceutical Inspectorate has ordered an immediate nationwide recall of a strong painkiller due to the detection of an unidentified impurity.
Immediate Recall of Painkiller
The Chief Pharmaceutical Inspectorate (GIF) has issued a decision for the immediate withdrawal from the market of a series of a strong painkiller. The decision applies throughout Poland and has been issued with immediate enforceability.
GIF is alerting patients to the recall.
Which Medication Has Been Recalled?
The recalled product is a prolonged-release tablet, 30 tablets per package, with GTIN number 05909990743827. The recall applies to a specific series.
Reason for GIF’s 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?
According to national consultants, substitution therapy is possible. This means the medication can be replaced with another prolonged-release morphine preparation at the same dosage (10 mg). Patients should consult with a doctor or pharmacist before changing treatment.
What Should Patients Do with the Recalled Painkiller?
Individuals who have the medication from series H01295 at home should take the following steps:
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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