OTC Pain Reliever Under Recall

Granules USA Inc is recalling a single lot of naproxen sodium tablets distributed in New York state. The recall was included in the September 8, 2021, US Food and Drug Administration (FDA) Enforcement Report, which cited deviations from Current Good Manufacturing Practice regulations but did not provide specifics.

The recall affects naproxen sodium tablets, 220 mg (NDC 62207-762-36), from lot 7620060a. The lot’s expiration date was not included in the report, although it did state the tablets were manufactured by Granules India Limited, Telangana, India.

Granules USA voluntarily initiated the recall August 11, 2021. On August 27, 2021, the FDA designated the recall Class II. Medications affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Naproxen sodium tablets are available over the counter to relive pain and fever.