Recalls / Class II
Class IID-0212-2025
Product
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.
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 0904-7044, 0904-7043, 0904-7045
- FDA application
- ANDA090778
- Affected lot / code info
- Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
Why it was recalled
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- a) 6408 boxes and b)1488 boxes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-01-13
- FDA classified
- 2025-01-29
- Posted by FDA
- 2025-02-05
- Terminated
- 2026-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0212-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.