Recalls / Class II
Class IID-1111-2018
Product
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
- Affected lot / code info
- Expiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239
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
- 531 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-1111-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.