D-1146-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2018
- Initiation Date
- August 20, 2018
- Termination Date
- October 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 bottles of 90 tablets (270 tablets overall)
Product Description
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
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution Pattern
South Carolina
Code Information
70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019