Hyderabad, Sep 13 : Granules India Limited announced Today that Granules USA, Inc., a wholly-owned foreign subsidiary of the Company located in New Jersey, New York, has voluntarily recalled one batch of Naproxen Sodium 220 mg tables at a retail level due to a minor ‘ CGMP deviation’
In a statement, while responding to a certain media article on the issue, the Hyderabad-based Pharmaceutical company confirmed that one batch has 11.4 million units of Naproxen tablets out of which 0.9 million units were released into the market were recalled.
Financially, this does not have a material impact on the company, it said.
“Granules manufactured and released a batch using Active Pharmaceutical Ingredient (API) from an alternate source prior to the final approval of a filed Prior Approval Supplement.
We have since received the authorization to use the API for this ANDA. There was absolutely no harm done at a patient-level because the API used in the batch is from an FDA approved source.” said G. N. Prashanth, Senior Vice President & Head Corporate Quality Assurance – Granules India Limited.
Granules have not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date, the statement added. (UNI)