Another medicinal product withdrawn from the market. Does not meet quality requirements
The Chief Pharmaceutical Inspector (GIF) issued a notice withdrawing a medicinal product called Omegaflex special from the market. This is important information for a wide range of patients. Find out the details of the decision.
Omegaflex special is a medicinal product used in parenteral nutrition. It involves giving the patient all the nutrients necessary for the proper functioning of the body directly into the bloodstream (bypassing the digestive system). This method is used, among others, in patients with gastrointestinal obstruction, enteritis, cancer, pancreatitis, burns of the mouth and throat, as well as chronic renal failure.
Omegaflex special – GIF decision details
In a published statement, the Chief Pharmaceutical Inspectorate provided details of the withdrawn batch of the medicinal preparation:
Omegaflex special, combined product, emulsion for infusion
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GTIN: 05909991317690,
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series number: 234818231,
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validity date: October 31, 2025
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responsible entity: B. Braun Melsungen AG, based in Melsungen, Germany
GIF has withdrawn the indicated series of the preparation from sale throughout the country. Moreover, he banned its introduction to the market. Both decisions were made immediately enforceable.
Why was Omegaflex special withdrawn?
The Chief Pharmaceutical Inspector received information about complaints reported by customers throughout Poland. All of them concerned the indicated batch of Omegaflex special. A quality defect was detected. These are discolored oxygen indicators.
“As a result of the investigation activities, the manufacturer identified the cause of the non-compliance in the form of a problem with the welding machine used at the end of the production of the drug batch (…). The above-mentioned problem resulted in insufficient welding of the sides of the outer bags, which allowed air and oxygen to penetrate inside them” – we read in the GIF message.
It is worth emphasizing that this defect may lead to a change in the properties of the medicinal preparation (the emulsion should not be exposed to oxygen). Taking into account the safety of patients taking the preparation, the Chief Pharmaceutical Inspector decided to withdraw the defective batch from sale.
