Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
Lot numbers, UPCs & expiration codes
Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195
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-1110-2018
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 17, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- 524 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A-S Medication Solutions LLC.
Original FDA data
Every field from FDA enforcement report D-1110-2018, exactly as published.
Show all FDA fields
- City
- Libertyville
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 80748
- Address
- 2401 Commerce Dr
- Code information
- Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195
- Postal code
- 60048-4464
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1110-2018
- Classification
- Class II
- Recalling firm
- A-S Medication Solutions LLC.
- Product quantity
- 524 bottles
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jul 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2018