Class II
Ongoing
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
- Company
- A-S Medication Solutions Llc.
- Recall Initiated
- July 17, 2018
- Posted
- August 29, 2018
- Recall Number
- D-1109-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 178 bottles
- Firm Location
- Libertyville, IL, United States
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Nationwide USA
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
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