FDAFDA · Food and drugs·Recall number D-1146-2018
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Published September 5, 2018 · Recall initiated: August 20, 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 · E-Mail
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- South Carolina
- Lot
- 70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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