Recalls / Class II
Class IID-0124-2024
Product
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
- Brand name
- Naproxen Sodium
- Generic name
- Naproxen Sodium
- Active ingredient
- Naproxen Sodium
- Route
- Oral
- NDCs
- 68462-178, 68462-188, 68462-189, 68462-190, 68462-179
- FDA application
- ANDA078314
- Affected lot / code info
- Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025
Why it was recalled
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-11-07
- FDA classified
- 2023-11-27
- Posted by FDA
- 2023-12-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0124-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.