FDA recall D-0093-2019

Product

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

Reason for recall

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Distribution

Product was distributed to a medical facility in South Carolina

Key facts

Status

Terminated

Initiation date

2018-08-24

Report date

2018-10-31

Termination date

2018-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2019