Drug recall D-0124-2024

Class II Ongoing reported Dec 6, 2023

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.

Reason for recall

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Lots and codes

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

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 7, 2023

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