FDA-Drug2025-04-09Class III
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Sold states
Nationwide in the USA
Affected count
224 cartons
Manufactured in
341 Mason Rd, La Vergne, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2025Don't want to check this manually?
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