FDA-Drug2019-11-20Class II

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.

Golden State Medical Supply Inc.
Hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

Sold states
AZ, IA, MA, MO
Affected count
N/A
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0308-2020

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