
The reason for the recall was that the batch did not meet the safety criterion for the indicator “Bacterial endotoxins”.
The pharmaceutical company MOSFARM is recalling a batch of the antibiotic Linezolid from circulation due to non-compliance with safety requirements for the indicator “Bacterial endotoxins”, according to a document from Roszdravnadzor.
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The MOSFARM company decided to recall a batch of the Linezolid antibiotic, series 0150526, due to non-compliance with the requirements for the “Bacterial endotoxins” indicator.
MOSCOW, September 7 - RIA Novosti. The pharmaceutical company MOSFARM decided to withdraw a batch of the antibiotic Linezolid from circulation due to non-compliance with safety criteria, according to a document from Roszdravnadzor, which was reviewed by RIA Novosti.
Linezolid is an antibiotic that belongs to a new class of antimicrobial agents - oxazolidinones. It acts on bacteria in a unique way, so there is no cross-resistance with other classes of antibiotics.
“The Federal Service for Surveillance in Healthcare informs about the decision taken by the manufacturer, MOSFARM LLC, to recall from circulation the drug “Linezolid, solution for infusion 2 mg/ml 300 ml, bottles (15), cardboard boxes” series 0150526 due to the non-compliance of the batch of this series of the drug with the established requirements for the indicator “Bacterial endotoxins,” the document says.
The “Bacterial endotoxins” indicator is a critically important safety criterion, primarily for drugs that are administered parenterally to the body (injections, infusions). It allows you to normalize the content of pyrogenic impurities - substances that can cause a febrile reaction in a person (increase in temperature).

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