Drug Enforcement D-0123-2024

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

Status

Ongoing

Classification

Class II

Report Date

December 6, 2023

Termination Date

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Product Information

Product description
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
Product quantity
37,200 bottles
Reason for recall
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0123-2024
Event ID
93368
Recall initiation date
November 7, 2023
Center classification date
November 27, 2023
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
More code info
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