Mosfarm Recalls Linzolid Batch Over Safety Concerns
A batch of the antibiotic Linzolid produced by Mosfarm was recalled in Russia due to non-compliance with safety requirements for bacterial endotoxins. The recall affects the 2 mg/ml infusion solution in 300 ml bottles, with the issue linked to pyrogenic impurities that could cause fever in patients.
Consensus
- Mosfarm recalled a batch of the antibiotic Linzolid from circulation in Russia.
- The recall was due to non-compliance with safety requirements regarding bacterial endotoxins.
- The affected product is a 2 mg/ml infusion solution in 300 mL bottles.
- Bacterial endotoxins are pyrogenic impurities that can cause fever in patients.
- The product is used for treating infections such as pneumonia, skin infections, and osteomyelitis.
- The drug belongs to the oxazolidinone class of antimicrobial agents.
- The mechanism of action of Linzolid prevents cross-resistance with other antibiotic classes.
- The recall was based on a document from Roszdravnadzor, which was accessed by RIA Novosti.
Points of divergence
- On September 4, the Russian Ministry of Health suspended the registration of the drug Decaris from the Hungarian company Gedeon Richter due to a threat to human health, with registration not to be restored until the manufacturer provides necessary information. — vedomosti
- On August 27, a representative of Farmasintez informed Vedomosti about launching enavogliflozin for type 2 diabetes therapy in Russia, registered by the Ministry of Health on July 24 under the brand name Nexaglyf. — vedomosti
- On August 19, the Russian Ministry of Health registered the drug Areima for immunotherapy of triple-negative breast cancer. — vedomosti
Coverage (3 sources)
- Mosfarm recalls a batch of the antibiotic linezolid — Ведомости
- In Russia, a batch of the antibiotic 'Linezolid' has been withdrawn from circulation — Коммерсантъ
- Antibiotic "Linezolid" batch recalled from circulation in Russia — Вести