Pharma & Drug Safety

Neonatal incubator safety alert: Lifetherm 2000

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

Stryker Osteosynthesis Screws Recalled Due to Safety Concerns

The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.

Product Recall: Mako Surgical Corp. MICS3 Fixation Device

The ANSM has announced a product recall for the Mako Surgical Corp. MICS3 fixation device, registered under recall number R2606434. The recall targets pharmacies and healthcare facilities, with two identified users having received direct communication from the manufacturer.

Polysilane UPSA gel oral recall notice

The ANSM has issued a recall notice for specific lots of Polysilane UPSA oral gel due to the potential presence of food-grade joint particles. The recall is a precautionary measure affecting the distribution chain, and the product will be unavailable until the issue is resolved.

Pure Vitamins LLC Recalls Honey Products Due to Undeclared Sildenafil and Tadalafil

Pure Vitamins and Natural Supplements, LLC is voluntarily recalling honey products marketed as sexual enhancement due to undeclared sildenafil and tadalafil. These undeclared ingredients can interact with prescription medications and cause dangerous drops in blood pressure.

DEA Notice: Stepan Company Application for Bulk Controlled Substance Manufacturer

The DEA has published a notice regarding Stepan Company's application to be registered as a bulk manufacturer of cocaine and ecgonine. Interested parties can submit comments or requests for a hearing by May 12, 2026.

DEA Notice: Lonza Tampa LLC Application for Controlled Substance Importer Registration

The DEA has published a notice regarding an application from Lonza Tampa, LLC to be registered as an importer of psilocybin (Schedule I controlled substance). Interested parties can submit comments or requests for a hearing by April 13, 2026.

DEA Notice: Patheon API Services Controlled Substance Application

The DEA has published a notice regarding an application from Patheon API Services Inc. to be registered as a bulk manufacturer of controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or requests for a hearing by May 12, 2026.

DEA Designates Propionyl Chloride as List I Chemical

The DEA has finalized a rule designating propionyl chloride as a List I chemical under the Controlled Substances Act. This action subjects handlers of propionyl chloride to regulatory provisions due to its use in the illicit manufacture of fentanyl and its analogues. The rule becomes effective on April 9, 2026.