Valsartan Tablets USP recall: Impurity Out of Spec
Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
Why was Valsartan Tablets USP recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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?
Batch: BV48D001, BV48D002
- Product
- Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- ALL
- Distribution
- Nationwide USA
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)