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Granules USA, Inc., a wholly-owned foreign subsidiary of Granules India Ltd is voluntarily recalling one batch of Naproxen Sodium 220mg tablets at a retail level due to a minor “CGMP deviation”.
One batch has 11.4 million units of Naproxen tablets, out of which 0.9 million units that were released into the market were recalled. Financially, this does not have a material impact on the company.
“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 authorisation 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.” GN Prashanth, Senior Vice President & Head Corporate Quality Assurance – Granules India Ltd said in a release.
Granules has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date, it added.
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