Recalls / Class II

Class IID-1109-2018

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

Affected lot / code info

Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170

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

178 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-1109-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.