Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Barde
Summary
The FDA issued a Class II for Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Gle by Glenmark Pharmaceuticals Inc., USA. Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen.
Details
Source
Drug Recall
External ID
D-0123-2024
Action Date
2023-12-06
Status
Ongoing
Category
drug
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
Lot/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
Quantity Affected: 37,200 bottles
Reason for Recall
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-07
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0123-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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