REGULATORY INTELLIGENCE·Warning Letter
Dr. Reddy's Sirolimus Recall: Impurity Breach Triggers Class III Action, Demanding Supply Chain Review
Dr. Reddy's Laboratories, Inc. has initiated a Class III recall for Sirolimus Tablets 1mg across the U.S. due to failed impurity and degradation specifications. This event necessitates immediate action from procurement and regulatory teams to assess supply chain exposure and ensure product quality for this critical immunosuppressant, highlighting persistent challenges in generic pharmaceutical manufacturing oversight.
90-Day Activity