Amlodipine recall: Impurity Out of Spec
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent…
Why was Amlodipine 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: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003
- Product
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 34320 bottles
- Distribution
- Nationwide USA
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)