The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall
Recall #D-0212-2025 · 01/13/2025
Class II: Risk
Recall Details
- Recall Number
- D-0212-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Status
- Completed
- Date Initiated
- 01/13/2025
- Location
- La Vergne, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 6408 boxes and b)1488 boxes
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Product Description
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Distribution Pattern
Nationwide within the United States
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.