GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Recall Number: D-0308-2020
Firm: Golden State Medical Supply Inc.
Classification: Class II
Status: Terminated
Report Date: 20191120
Initiation Date: 20191106
Termination Date: 20210415
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Product Description
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.