Roszdravnadzor Stops Circulation of Mesacol Batch JMF1193A — 9 September 2026
- 09-09-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
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Roszdravnadzor has stopped circulation of batch JMF1193A of Mesacol 400 mg, manufactured by Sun Pharmaceutical Industries Ltd (India).
The action is based on nonconformity with requirements for mesalazine identity, dosage uniformity, and quantitative determination. The batch owner, Rigla LLC, was instructed to withdraw and destroy the batch. Market participants must take measures to eliminate the risk of harm to patients.
Official documents:
Information letter No. 02И-1030/26: https://roszdravnadzor.gov.ru/drugs/qualitycontrol/documents/91176
PDF: https://roszdravnadzor.gov.ru/i/upload/images/2026/9/8/1788877928.76296-1-3562836.pdf