Recalls / Class II
Class IID-1110-2018
Product
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
- Affected lot / code info
- Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- A-S Medication Solutions LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2401 Commerce Dr, Libertyville, Illinois 60048-4464
Distribution
- Quantity
- 524 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-07-17
- FDA classified
- 2018-08-18
- Posted by FDA
- 2018-08-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1110-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.