Drug & medication recalls

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Dist…

Recall date
March 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0304-2025
FDA classification
Class III
Brand / firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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.

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