Amlodipine and Valsartan Tablets USP 10mg/160mg recall: Impurity Out of Spec
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo…
Why was Amlodipine and Valsartan Tablets USP 10mg/160mg recalled?
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot Numbers: VFSA17007-A, exp. date Oct-2019
- Product
- Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo…
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- N/A
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)