Agency classClass IIOur severity:Severe FDA (Drugs)·D-1095-2018·Announced 2018-08-22

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: carcinogen-impurity
cgmp-deviation
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.

See all 4 products in this recall →

Same manufacturer · Northwind Pharmaceuticals LLC

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Same hazard · carcinogen impurity