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Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceutic...

FDA Recall #D-0643-2020 — Class II — December 17, 2019

Recall #D-0643-2020 Date: December 17, 2019 Classification: Class II Status: Ongoing

Product Description

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

500,960 bottles

Distribution

Natiowide

Code Information

7701069A 7701070A 7701084A 7701085A 7701087A 7701094A 7701095A 7701140A 7701141A 7701142A 7701157A 7701162A 7701182A 7701217A 7701218A 7701219A 7701236A 7701237A 7701220A 7701456A 7701470A 7701520A 7701671A 7701696A 7701697A 7701698A 7701797A 7701928A 7701929A 7701942A 7701943A 7702065A 7702066A 7702067A 7702095A 7702096A 7702097A 7702098A 7702188A 7702189A 7702190A 7702196A 7702197A 7702198A 7702199A 7702348A 7702338A 7702347A 7702349A 7702350A 7702391A 7702392A 7702546A 7702547A 7702548A 7702616A 7702617A 7702618A 7702619A 7702620A 7702763A 7702764A 7702851A 7702852A 7702853A 7702854A 7702855A 7702868A 7702869A 7702870A 7702871A 7702920A 7703054A 7703055A 7703056A 7703057A 7703058A 7703206A 7703208A 7703454A 7703455A 7703456A 7703486A 7703487A 7703488A 7703489A 7703490A 7703945A 7703946A 7703947A 7704111A 7704112A 7704113A 7704234A 7704235A 7704236A 7704237A 7704285A 7704286A 7704287A 7704288A 7704370A 7704371A 7704428A 7704429A 7704430A 7704431A 7704814A 7704838A 7704839A 7704840A 7704935A 7704936A 7704992A 7704996A 7704997A 7704998A 7704999A 7705037A 7705298A 7705299A 7705300A 7705301A 7705302A 7705303A 7705546A 7705584A 7705544A 7705545A 7705572A 7705585A 19190456 19190472 19190490 19191934 19191942 19191959 19192504

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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