Class II
Terminated
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
- Company
- Remedyrepack Inc.
- Recall Initiated
- August 20, 2018
- Posted
- September 5, 2018
- Recall Number
- D-1146-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3 bottles of 90 tablets (270 tablets overall)
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution
South Carolina
Lot / Code Info
70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
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