Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Recall Number: D-0017-2021
Firm: Direct Rx
Classification: Class II
Status: Terminated
Report Date: 20201014
Initiation Date: 20200115
Termination Date: 20201207
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Product Description
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30