Granules India is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout, and fever.
According to USFDA, the company's US-based unit is recalling the affected lot due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot has been manufactured at Granules India's Telangana-based plant. The lot has been distributed in the US by New Jersey-based Granules USA, Inc, the report stated. Granules initiated the Class II voluntary recall on August 11 this year.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
