FDA recall D-0124-2024

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2023-11-07

Report date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2024