FDA recall D-0304-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class III · 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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2025-03-04
Report date: 2025-04-09
Termination date: 2026-02-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2025