Recall D-0304-2025
Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, TN
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 for recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.