FDAClass IINovember 15, 2023

Ranolazine Extended-Release Tablets 500mg recall: Failed Dissolution

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2…

Why was Ranolazine Extended-Release Tablets 500mg recalled?

Failed Dissolution Specifications: Out of specification for dissolution.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot # 17230388, Exp. 01/31/2025

Product
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
16,944 bottles
Distribution
Nationwide
Recall date
November 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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