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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