Sun Pharmaceutical Industries Inc Presence of foreign substance: identified as aluminum.
Class II · Ongoing
Sep 3, 2013
Pfizer Us Pharmaceutical Group Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).