Overview
- Disposition 13/2026 prohibits nationwide use, sale and distribution of all P. L. Rivero lots manufactured at Solkotal and orders their market recovery.
- A provider’s query prompted checks that uncovered unapproved subcontracted manufacturing, incomplete documentation, uncalibrated equipment and quality-system failures at the Solkotal facility.
- Preventive inhibitions remain in place for Biotenk S.A. and Laboratorios Solkotal S.A. after INAME documented critical breaches in pharmacovigilance and Good Manufacturing Practices.
- Eight establishments lost operating authorization, including Laboratorio Apolo, after regulators found no active production and no designated technical director as required by Law 16.463.
- Additional measures revoke Correo Argentino’s secondary-packaging authorization at its Malvinas Argentinas plant, prohibit two stolen CGuard Prime carotid stents, and cancel Spedrog Caillon’s license along with nine REM certificates.