Boxes of Modolex Drug Contain the Correct Active Ingredient
Lek Pharmaceuticals d.d. hereby announces that they have issued, in accordance with Article 66 of the Act on Medicinal Products and Medical Devices, a written notification to wholesale drugstores, to the Agency for Medicinal Products of the Republic of Slovenia, to the Public Health Inspectorate of the Republic of Slovenia and to the Institute of Pharmacy and Drug Research, immediately after receiving an official notice of the non-conformity of the packaging material in one batch of the product Modolex. Lek regrets the occurrence of the mistake, but gives an assurance that the boxes of the drug Modolex contain the correct active ingredient.
On January 15, 2003, the pharmaceutical company, Lek, received an official notice of the non-conformity of the packaging material for Modolex suppositories, atch No. 002164807D. In accordance with the regulations, the Company issued to its distributors on the same day a notification to stop the distribution of the drug and blocked the stock of the defective products of the above-indicated batch. After the product sample analysis, Lek confirmed on Thursday, January 16, the product identity and sent a written notification to the wholesale drugstores, asking them to immediately inform their customers about the situation. An identical notification was submitted by the Company to the competent authorities, i.e., the Agency for Medicinal Products of the Republic of Slovenia, to the Public Health Inspectorate of the Republic of Slovenia and to the Institute of Pharmacy and Drug Research.
Lek has established that during the process of packaging the Modolex suppositories, an antihemorrhoidal, the wrong packaging foil was used. One segment of the batch of the Modolex suppositories was packaged into the foil bearing the marking for Ketonal suppositories, which is an analgesic, anti-inflammatory and antipyretic drug. Considering the fact that the active ingredient of Modolex, its external packaging (boxes), and the product information are correct, we strongly believe that the use of the drug for the well-known indications is safe, presenting virtually no health risk. If used as an analgesic for the indications of Ketonal, the active ingredient of Modolex would only produce a local analgesic effect.
Non-conformity of the packaging material does not threaten patients’ health. Lek has recalled from circulation only the batch No. 002164807D. It has issued a timely notification of the recall to all those wholesale drugstores and pharmacies to which the batch in question had been distributed.
Lek regrets the occurrence of the mistake in the packaging material of the batch at issue. The Company operates in conformity with the GMP (Good Manufacturing Practice) standards, providing safety, efficacy and quality of its drugs. In accordance with these standards, we have implemented the necessary corrective measures.
This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
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For additional information, please contact: + 386 1 580 22 43 Miša Komar iberna, Lek’s Corporate Communications