Northwind Recalls Valsartan HCTZ Tablets Due to Carcinogen Impurity
Northwind Pharmaceuticals is recalling 43 bottles of Valsartan HCTZ 160/12.5mg 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' (FDA Class II with significant injury/property-damage reports or high-risk hazards).
Plain-English summary
Northwind Pharmaceuticals LLC is recalling 43 bottles of Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle. The product is identified by NDC 51655-950-52, Lot UTB23790003, and an expiration date of 02/28/2019. The recall was initiated 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 was distributed in Indiana. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these specific tablets.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
- Manufacturer
- Northwind Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 43
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: UTB23790003
- exp 02/28/2019
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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