PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: December 6, 2023 Initiated: November 7, 2023 #D-0124-2024

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

Details

Distribution
Nationwide
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Glenmark Pharmaceuticals Inc., USA.
Why was this product recalled?
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2023. Severity: Moderate. Recall number: D-0124-2024.