FDAFDA · Food and drugs·Recall number D-0093-2019
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
Published October 31, 2018 · Recall initiated: August 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to a medical facility in South Carolina
- Lot
- Lot # B0438903-052118 70518-1220-00
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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