FDA Drugs recall ·
Rufinamide Tablets 200mg, 120-count bottle, Rx Only… recall
- Recall number
- D-0323-2025
- Date
- (initiated March 13, 2025)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
750 Corporate Dr, Mahwah, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-25
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0323-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.