Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Lot numbers, UPCs & expiration codes
Lot # 111158; Exp. 02/19
Where it was sold
Product was distributed in HI, IN, and FL.
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-1027-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 690 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack Inc.
Original FDA data
Every field from FDA enforcement report D-1027-2018, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80634
- Address
- 1919 N Victory Pl
- Code information
- Lot # 111158; Exp. 02/19
- Postal code
- 91504-3425
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1027-2018
- Classification
- Class II
- Recalling firm
- Bryant Ranch Prepack Inc.
- Product quantity
- 690 tablets
- Termination date
- Apr 22, 2021
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Distribution pattern
- Product was distributed in HI, IN, and FL.
- Recall initiation date
- Jul 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2018