The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall
Recall #D-0304-2025 · 03/04/2025
Class III: Low Risk
Recall Details
- Recall Number
- D-0304-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Status
- Ongoing
- Date Initiated
- 03/04/2025
- Location
- La Vergne, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 224 cartons
Reason for Recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Product Description
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
View all recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.