FDA-Drug2019-11-20Class II

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20

Novitium Pharma LLC
Hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

Sold states
Nationwide
Affected count
19560 bottles
Manufactured in
70 Lake Dr, N/A, East Windsor, NJ, United States
Products
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0310-2020

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