A-S Medication Solutions Recalls Valsartan Tablets Due to Carcinogen Impurity
A-S Medication Solutions LLC is recalling Valsartan Tablets 160 MG because a carcinogen impurity was detected in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a carcinogen impurity, which aligns with the rubric criterion for Severe (Score 4) involving significant injury risk or high-risk contaminants.
Plain-English summary
A-S Medication Solutions LLC is voluntarily recalling 666 bottles of Valsartan Tablets, 160 MG, in 30-count and 90-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product.
The affected product is manufactured by Zhejiang Huahai Pharma in Linhai, Zhejiang, China. The recall covers specific lot numbers and expiration dates for both 30-count (NDC 54569-6583-0) and 90-count (NDC 54569-6583-1) bottles. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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
- Manufacturer
- A-S Medication Solutions LLC.
- Category
- Drug — Prescription Medication
- Affected units
- 666
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by A-S Medication Solutions LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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