Ranitidine recall – Novitium Pharma LLC.

November 01, 2019

On October 25, 2019, Novitium Pharma LLC (Novitium) issued a voluntary recall of Ranitidine 150mg capsules, and 300mg capsules due to an elevated amount of an unexpected impurity (NDMA) found in the active pharmaceutical ingredient.

The FDA recommends speaking with your prescriber if you want to stop your medication or use an alternative medication.

Description	Strength	Type	Pack Size	NDC
Ranitidine Capsules 150mg	150 mg	Rx	60 ct bottle	70954-001-20
Ranitidine Capsules 150mg	150 mg	Rx	500 ct bottle	70954-001-40
Ranitidine Capsules 300mg	300 mg	Rx	30 ct bottle	70954-002-10
Ranitidine Capsules 300mg	300 mg	Rx	100 ct bottle	70954-002-40

Additional information is available on the FDA's website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg#recall-announcement

Last updated: December 08, 2023

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