FDAHealthMarch 4, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distrib
⚠️ Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 4, 2025
Nationwide in the USA
What's affected?
- 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.
- Brand
- TOLTERODINE TARTRATE
- Lot code
- T05393
Additional details
Lot# T05393, Exp. Date: 09/30/2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 224 cartons.
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