Class III Recall

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Product
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Reason
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Classification
Class III
Status
Terminated
Lot
Lot# T05393, Exp. Date: 09/30/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.