The Recall Desk
SevereFDA (Drugs)·D-1176-2018·Announced 2018-09-12

AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

AvKARE is recalling Valsartan and Hydrochlorothiazide 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 constitutes a significant health risk and fits the 'Severe' criteria for significant injury or high-risk contamination.

Plain-English summary

AvKARE Incorporated is recalling specific lots of AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets. The recall involves 12,950 bottles of the 90-count prescription medication, which were distributed nationwide.

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 lots include 17780, 18029, 18398, 18723, 19017, 19224, 20032, 20289, 21076, and 21382, with expiration dates ranging from September 2018 to August 2019.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. Patients should consult their healthcare provider for alternative treatment options.

The recalled product

Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
Manufacturer
Avkare Incorporated
Category
Drug — Antihypertensive
Hazard
Affected units
12,950

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 (10)

  • Lots: 17780 Exp. 09/2018
  • 18029 Exp. 09/2018
  • 18398 Exp. 09/2018
  • 18723 Exp. 09/2018
  • 19017 Exp. 02/2019
  • 19224 Exp. 02/2019
  • 20032 Exp. 08/2019
  • 20289 Exp. 08/2019
  • 21076 Exp. 08/2019
  • 21382 Exp. 08/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Avkare Incorporated 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 5 products in this recall →

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Same hazard · carcinogen impurity

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