The Recall Desk
SevereFDA (Drugs)·D-1052-2019·Announced 2019-03-27

Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

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, which corresponds to a Severe rating under the rubric, particularly given the presence of a nitrosamine impurity (NDEA) in a prescription medication.

Plain-English summary

Rising Pharmaceuticals, Inc. is recalling Valsartan Tablets 40 mg USP, 30 tablet bottles. The product is distributed by Acetris Health, LLC, and manufactured by Aurolife Pharma LLC. The recall involves 30,530 bottles with specific lot codes and expiration dates listed in the agency record.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the detection of a trace amount of the unexpected impurity N-nitrosodiethylamine (NDEA) in the finished products. The product was distributed to six major distributors, who may have further distributed the product throughout the United States.

Consumers and healthcare providers should check their inventory for the specific NDC 52343-122-30 and the listed lot codes. If the product is found, it should be returned to the distributor or pharmacy for disposal or replacement in accordance with standard recall procedures.

The recalled product

Product
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
Manufacturer
Rising Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
30,530

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)

  • 470170038A
  • exp. date 10/31/2019 470180010A
  • exp. date 02/29/2019 470180012A
  • exp. date 03/31/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Rising Pharmaceuticals, Inc. 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 →

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Same hazard · nitrosamine impurity

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