Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Recall Number: D-0016-2021

Firm: Direct Rx

Classification: Class II

Status: Terminated

Report Date: 20201014

Initiation Date: 20200115

Termination Date: 20201207

CGMP Deviations: Presence of NDMA impurity detected in product.

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534