FDA Recall D-1109-2018
A-S Medication Solutions LLC. · Libertyville, IL
Class II Ongoing 2858 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall record
- Recall number
D-1109-2018- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA
- Recall initiated
- 2018-07-17
- Classified by FDA Center
- 2018-08-18
- FDA published
- 2018-08-29
- Recalling firm
- A-S Medication Solutions LLC.
- Firm location
- Libertyville, IL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.