Russian health authorities have begun withdrawing a batch of the strong painkiller Ketorolac from circulation across Russia after it failed quality control tests.
The nationwide recall order was issued after an official letter from federal healthcare regulator Roszdravnadzor revealed that a specific series of the medication produced by PJSC Synthez failed inspection due to impurities, according to reports by Telegram channel Shot.
The recall applies specifically to Ketorolac solution for intravenous and intramuscular injection with a concentration of 30 milligrams per millilitre in one-millilitre ampoules, packaged in 10-ampoule cardboard boxes. Roszdravnadzor specified that the order targets series 170924, directing healthcare facilities and distributors to remove all existing stock of this batch from circulation and destroy it.
Pharmaceutical quality control and regulatory oversight
Ketorolac is a potent nonsteroidal anti-inflammatory drug prescribed for the management of acute and severe pain. PJSC Synthez is a major Russian pharmaceutical manufacturing company that produces generic medications, antibiotics and specialized medical solutions for hospital networks and retail pharmacies nationwide.
In pharmaceutical regulation, a batch or series number identifies a single production run manufactured under identical conditions. As the Federal Service for Surveillance in Healthcare, Roszdravnadzor oversees safety compliance across the Russian medical market. When laboratory analysis identifies unauthorized impurities or deviation from safety standards, the agency orders mandatory withdrawal and disposal to protect public health.
Supply status of anxiety medication Atarax
In the same regulatory update, Roszdravnadzor responded to recent media reports alleging shortages of the anti-anxiety medication Atarax in several Russian regions.
The healthcare regulator stated that more than one million packages of medications containing the active substance under the international nonproprietary name Hydroxyzine are currently available in civilian circulation nationwide. Authority representatives clarified that roughly half of these supplies are marketed and sold under the trade name Atarax.
Government representatives affirmed that current volumes of production, delivery and entry into civilian circulation for Hydroxyzine medicines remain consistent with average annual levels recorded in previous years. Hydroxyzine is an anxiolytic medication widely used to treat anxiety disorders, and officials maintained that national supplies remain stable.
