The Chief Pharmaceutical Inspectorate (GIF) decided to retreat 5 series of Elenium from the market. As indicated by the Authority, "the established defect may be applicable to all doses, i.e. 5 mg, 10 mg and 25 mg, which have been repacked".
The GIF decision was announced April 9, 2025 and includes an immediate ban on the marketing and placing on the marketplace of defective batches.
Which Elenium series are being withdrawn?
The GIF gave the exact indications of withdrawn lots:
- Elenium (Chlordiazepoxidum), 5 mg coated tablets
- GTIN: 05909990215409
- Serie:
- 11221 ( EXP 11.2025)
- 31222 ( EXP: 10.2026)
- Elenium (Chlordiazepoxidum), 10 mg coated tablets
- GTIN: 05909990215089
- Serie:
- 30122 ( EXP 12.2025)
- 50622 ( EXP 05.2026)
- Elenium (Chlordiazepoxidum), 25 mg coated tablets
- GTIN: 05909990219537
- Batch:
- 10423 ( EXP: 10.2026)
The reason for withdrawal is the non-compliance with the release rate parameter of the active substanceThis may affect the effectiveness of the medicine. The problem is most likely due to repacking the tablets. The company requested it. Tarchomińskie Zakłady Pharmaceuticaluczne ‘Polfa’ S.A.who reported irregularities.
Immediate GIF Decision
Decision of the Chief Pharmaceutical Inspectorate has been subject to immediate enforceability, which means that the medicine must be immediately withdrawn from the pharmacy and sales points.
Other case: withdrawal of Cefazolin TZF
It's not the first GIF decision this year. At the end of January 2025. withdrawn from the marketplace Cefazolin TZF antibiotic due to a serious qualitative defect that may have been life-threatening.
Cefazolin TZF is utilized to treat serious infections, including:
- genitourinary system
- bones and joints,
- skin and soft tissue,
- respiratory and biliary disorders
It was besides utilized to treat pneumonia, endocarditis and sepsis, both in adults and children over 1 period of age. The withdrawal decision was besides taken upon application Tarchomiński Zakłady Pharmaceuticalznych “Polfa” S.A.
What if you have withdrawn series?
If you have a drug from the withdrawn series, do not take it and consult your doctor or pharmacist. Pharmacy should already retreat defective batches, but it is worth checking the packaging yourself.
Take care of your wellness – always check GIF messages!
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GIF withdraws Elenium – See if you have a defective series of medicines!9 April 2025
The Chief Pharmaceutical Inspectorate (GIF) decided to retreat 5 series of Elenium from the market. As the Authority points out, ‘the identified defect may be for all doses, i.e. 5 mg,
More here:
GIF withdraws Elenium – See if you have a defective series of medicines!
