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
Reported: September 5, 2018 Initiated: August 20, 2018 #D-1146-2018
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.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 3 bottles of 90 tablets (270 tablets overall)
- Distribution
- South Carolina
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RemedyRepack Inc.. Units affected: 3 bottles of 90 tablets (270 tablets overall).
Why was this product recalled? ▼
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2018. Severity: Moderate. Recall number: D-1146-2018.
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