GIF Recalls Popular Sedative Drug, Release Issue Detected
Two batches of the drug Elenium, used to treat anxiety, were withdrawn from circulation by the Chief Pharmaceutical Inspector. The decision was made after irregularities in the degree of release of the active substance were detected. The manufacturer reported the problem itself, and the inspection confirmed the risk to patients.
The Chief Pharmaceutical Inspector has decided to withdraw two batches of the drug Elenium (Chlordiazepoxidum) in a dose of 5 mg – a popular sedative preparation. This concerns batches numbered 10324 (valid until 02.2028) and 50125 (valid until 12.2028), manufactured by Tarchomińskie Zakłady Farmaceutyczne "Polfa" SA from Warsaw.
The decision was made immediately enforceable, which means that the withdrawal from sale must take place without delay.
The reason for the decision was irregularities detected in stability studies – the so-called out-of-specification (OOS) result for the parameter "active substance release rate". The studies were conducted after 12 months of drug storage in long-term conditions.
The manufacturer itself reported these irregularities to GIF. As explained in the documentation, the problem could have resulted from " progressive hardening of the tablet core and partial sealing of the shell under the influence of aging factors ."
On May 21-22, 2025, GIF inspectors conducted an inspection at the manufacturer. A number of inconsistencies were revealed, especially regarding the method of confirming the stability of the drug throughout its shelf life.
- On May 21-22, 2025, the Chief Pharmaceutical Inspector conducted an inspection at the manufacturer of the medicinal product Elenium. It revealed a number of inconsistencies related to the method of proving, on the basis of stability studies, that the drug Elenium complies with the specification during its validity period if stored under the conditions specified in the marketing authorization. Thus, the manufacturing inspectors of the Chief Pharmaceutical Inspectorate noticed the manufacturer's failure to ensure that Elenium sugar-coated tablets, packaged in a registered new type of packaging, are suitable for their intended use, meet the requirements of the marketing authorization and do not expose patients to the risk of insufficient safety of use, inadequate quality or effectiveness during their validity period - writes GIF.
During the risk analysis, the manufacturer assessed that a similar process could also occur in other batches of the drug Elenium. As a result, the drug's effectiveness could be reduced.
GIF emphasizes that disruption of the release of the active substance may affect the quality, effectiveness and safety of the drug, potentially exposing patients to a health risk.
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