Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10

Recall Number: D-0312-2020

Firm: Novitium Pharma LLC

Classification: Class II

Status: Terminated

Report Date: 20191120

Initiation Date: 20191025

Termination Date: 20210317

CGMP Deviations: Presence of NDMA impurity detected in product.

Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10