Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Lot numbers, UPCs & expiration codes
Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019
Where it was sold
U.S. Nationwide
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-1131-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 728 cartons (36,400 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1131-2018, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 80828
- Address
- 615 N 1st St
- Code information
- Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019
- Postal code
- 38478-2403
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1131-2018
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 728 cartons (36,400 tablets)
- Termination date
- May 7, 2020
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2018