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Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

FDA Recall #D-0798-2020 — Class II — December 11, 2019

Recall #D-0798-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

Reason for Recall

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

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

Product Type

Drugs

Product Quantity

4,486 tablets

Distribution

Product was distributed to two facilities in CA and NY.

Code Information

Lot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020

Status

Terminated

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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