Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet recall: Nitrosamine Impurity
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC…
Why was Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet recalled?
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
- Product
- Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC…
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 3 bottles of 90 tablets (270 tablets overall)
- Distribution
- South Carolina
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)