Drug product

GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.

D-0307-2020

November 06, 2019

Class II

Product summary

Firm: Golden State Medical Supply Inc.
Event: Event 84233
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0307-2020

Official wording

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

Code information: Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; GS025702, Exp. 10/31/2020; GS027272, Exp. 10/31/2020; GS027273, Exp. 05/31/2021.

Distribution pattern: AZ, IA, MA, MO

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