Drug product

Indomethacin 25mg Capsules, USP, 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 68462-406-01

D-0123-2024

November 07, 2023

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 93368
Status: Ongoing
Classification: Class II
Quantity: 37,200 bottles
Official record key: drug-enforcement:D-0123-2024

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up