D-0124-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2023
- Initiation Date
- November 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Reason for Recall
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Distribution Pattern
Nationwide
Code Information
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