FDAClass IISeptember 8, 2021

Naproxen Sodum Tablets USP 220 mg recall: CGMP Deviations

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village…

Why was Naproxen Sodum Tablets USP 220 mg recalled?

CGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

7620060a

Product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village…
Recalling firm
Granules USA, Inc.
Quantity
11,450,000 tablets
Distribution
NY
Recall date
September 8, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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