FDAClass IIJanuary 15, 2020

Glenmark Ranitidine Tablets USP 150 mg recall: Nitrosamine Impurity

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India…

Why was Glenmark Ranitidine Tablets USP 150 mg recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

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?

7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A

Product
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
208,668 bottles
Distribution
Natiowide
Recall date
January 15, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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