Class III
Terminated
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.
This recall has been terminated (originally issued April 9, 2025).
- Recall Initiated
- March 4, 2025
- Posted
- April 9, 2025
- Recall Number
- D-0304-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 224 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Distribution
Nationwide in the USA
Lot / Code Info
Lot# T05393, Exp. Date: 09/30/2025
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