Northwind Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Northwind Pharmaceuticals is recalling specific lots of Valsartan 160 mg 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 the detection of a carcinogen impurity represents a significant health risk, meeting the criteria for a Severe severity score.
Plain-English summary
Northwind Pharmaceuticals LLC is recalling 68 bottles of Valsartan, 160 mg, 30 tablets per bottle. The affected product is identified by NDC 51655-460-52 and includes Lot UT48320002 (exp 07/31/2018) and Lot UT48320003 (exp 05/31/2019). 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 units were distributed in Indiana. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or point of purchase for disposal or credit.
The recalled product
- Product
- Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
- Manufacturer
- Northwind Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Affected units
- 68
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 (4)
- Lot: UT48320002
- exp 07/31/2018
- Lot UT48320003
- exp 05/31/2019
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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