Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
Lot numbers, UPCs & expiration codes
Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019
Where it was sold
Indiana
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-1095-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 68 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Northwind Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-1095-2018, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 80703
- Address
- 9402 Uptown Dr Ste 1100
- Code information
- Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019
- Postal code
- 46256-1042
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1095-2018
- Classification
- Class II
- Recalling firm
- Northwind Pharmaceuticals LLC
- Product quantity
- 68 bottles
- Termination date
- Mar 25, 2023
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
- Distribution pattern
- Indiana
- Recall initiation date
- Jul 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2018