Granules recalls one batch of Naproxen Sodium 220 mg tablets

Hyderabad: Hyderabad-based Granules India announced that Granules USA, a wholly owned foreign subsidiary of the company located in New Jersey, NY, is voluntarily recalling one batch of Naproxen Sodium 220 mg tablets at a retail level due to a minor “Current Good Manufacturing Practice deviation”. Naproxen Sodium, a non-steroidal anti-inflammatory drug (NSAID), is used to […]

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Hyderabad: Hyderabad-based Granules India announced that Granules USA, a wholly owned foreign subsidiary of the company located in New Jersey, NY, is voluntarily recalling one batch of Naproxen Sodium 220 mg tablets at a retail level due to a minor “Current Good Manufacturing Practice deviation”.

Naproxen Sodium, a non-steroidal anti-inflammatory drug (NSAID), is used to reduce pain, fever, and inflammation.

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 said in a statement.

“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,” said G N Prashanth, senior VP & head Corporate Quality Assurance, Granules India.

Granules has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date.