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.
Reported: April 9, 2025 Initiated: March 4, 2025 #D-0304-2025
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.
Details
- Units Affected
- 224 cartons
- Distribution
- Nationwide in the USA
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 224 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 9, 2025. Severity: Low. Recall number: D-0304-2025.
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