WhichRecall
Class IIIReported 2025-04-09

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

Reason for Recall

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

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Recall Number
D-0304-2025
Classification
Class III
Status
Terminated
Category
drug
Initiated
2025-03-04
Reported
2025-04-09
Distribution
Nationwide in the USA
Code Info
Lot# T05393, Exp. Date: 09/30/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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