Recalls / Class II
Class IID-1108-2018
Product
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
- Affected lot / code info
- Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249
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
- 666 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-1108-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.