Product: 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.
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20191106
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated