The Recall Desk
SevereFDA (Drugs)·D-1053-2019·Announced 2019-03-27

Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

Rising Pharmaceuticals is recalling Valsartan Tablets 80 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as nitrosamine impurities) are categorized as Severe (Score 4), as they are not Class I but involve significant health risks.

Plain-English summary

Rising Pharmaceuticals, Inc. is recalling Valsartan Tablets 80 mg USP, 90 tablet bottles. The recall involves 37,410 bottles distributed by Acetris Health, LLC and manufactured by Aurolife Pharma LLC. The product was distributed to six major distributors who may have further distributed the product throughout the United States.

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 affected lots are identified by the following codes and expiration dates: 471170019A (exp. 10/31/2019), 471180006A (exp. 03/31/2020), 471180007A (exp. 03/31/2020), and 471180016A (exp. 05/31/2020).

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for 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 Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90
Manufacturer
Rising Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
37,410

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 (5)

  • 471170019A
  • exp. date 10/31/2019 471180006A
  • exp. date 03/31/2020 471180007A
  • exp. date 03/31/2020 471180016A
  • exp. date 05/31/2020

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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