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

Recall Number: D-0798-2020

Firm: RemedyRepack Inc.

Classification: Class II

Status: Terminated

Report Date: 20200129

Initiation Date: 20191211

Termination Date: 20200723

Reason for Recall

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

Product Description

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