Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

Recall Number: D-0643-2020

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20200115

Initiation Date: 20191217

Termination Date:

CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20