Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
Lot numbers, UPCs & expiration codes
Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
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-1141-2018
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 17, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 169,200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1141-2018, 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: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
- Postal code
- 07920-3856
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1141-2018
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 169,200 bottles
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2018