Ranitidine recall – Novitium Pharma LLC.

30 de Octubre del 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

Última actualización: 13 de Marzo del 2020