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Recall Observatory FDA recall evidence

Drug 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.

D-0304-2025

March 04, 2025

Class III

Product summary

Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event
Event 96416
Status
Terminated
Classification
Class III
Quantity
224 cartons
Official record key
drug-enforcement:D-0304-2025

Official wording

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

Code information: Lot# T05393, Exp. Date: 09/30/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification