FDAFDA · Food and drugs·Recall number D-0124-2024
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.
Published December 6, 2023 · Recall initiated: November 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide
- UPC
- 0368462189016
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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