Drug product

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

D-0640-2020

December 17, 2019

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 84516
Status: Ongoing
Classification: Class II
Quantity: 217,956 bottles
Official record key: drug-enforcement:D-0640-2020

Official wording

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

Code information: 7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372

Distribution pattern: Natiowide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

NDMA impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations