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Corrective action plan to address blister packs that do not meet U.S. child-resistant packaging requirements, there are no quality or efficacy issues.
March 19, 2020
By: Kristin Brooks
Managing Editor, Contract Pharma
Novartis announced a Consumer Product Safety Commission (CPSC)-approved corrective action plan after identifying certain blister card packages (blister packs) of SANDIMMUNE (cyclosporine capsules, USP) 100-mg soft gelatin capsules and NEORAL (cyclosporine capsules, USP) MODIFIED 100-mg soft gelatin capsules distributed in the U.S. do not meet child-resistant packaging requirements, posing a potential risk of harm. Novartis notified the CPSC and the FDA and is working closely with the CPSC to ...
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