Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx o...
FDA Recall #D-0304-2025 — Class III — March 4, 2025
Product Description
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.
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
224 cartons
Distribution
Nationwide in the USA
Code Information
Lot# T05393, Exp. Date: 09/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated