Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
Lot numbers, UPCs & expiration codes
Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1138-2018
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 17, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 66864 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1138-2018, exactly as published.
Show all FDA fields
- City
- Basking Ridge
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 80847
- Address
- 150 Allen Rd Ste 102
- Code information
- Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
- Postal code
- 07920-3856
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1138-2018
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 66864 bottles
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2018