Northwind Pharmaceuticals Recalls Valsartan 80mg Due to Carcinogen Impurity
Northwind Pharmaceuticals is recalling Valsartan 80mg tablets 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 severity (FDA Class II with significant health risks).
Plain-English summary
Northwind Pharmaceuticals LLC is recalling Valsartan, 80mg, 30 tablets per bottle, NDC 51655-0652-52. 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 identified by Lot UT48310002 with an expiration date of 10/31/2018. The recall involves 2 bottles of the medication, which were distributed in Indiana. The product is repackaged by Northwind Pharmaceuticals in Indianapolis, IN.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
- Manufacturer
- Northwind Pharmaceuticals LLC
- Category
- Drug — Antihypertensive
- Affected units
- 2
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 (2)
- Lot: UT48310002
- exp 10/31/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Northwind Pharmaceuticals 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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