The Recall Desk
SevereFDA (Drugs)·D-1174-2018·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 meets the rubric criteria for a Severe rating due to the potential for significant health consequences.

Plain-English summary

AvKARE, Inc. is recalling specific lots of AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets. The recall involves 24,796 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 17325, 17856, 18396, 18702, 19020, 19222, 20030, and 20381, with expiration dates ranging from September 2018 to April 2019.

Patients who have been prescribed this medication should consult 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
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
Manufacturer
Avkare Incorporated
Category
Drug — Antihypertensive
Hazard
Affected units
24,796

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 (8)

  • Lots: 17325 Exp. 09/2018
  • 17856 Exp. 09/2018
  • 18396 Exp. 09/2018
  • 18702 Exp. 02/2019
  • 19020 Exp. 02/2019
  • 19222 Exp. 02/2019
  • 20030 Exp. 04/2019
  • 20381 Exp. 04/2019

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 →

Related recalls

Same manufacturer · Avkare Incorporated

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Same hazard · carcinogen impurity

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