The Recall Desk
SevereFDA (Drugs)·D-1177-2018·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 the presence of a carcinogen impurity in a pharmaceutical product represents a significant health risk, aligning with the 'Severe' criteria for significant injury or high-risk contamination.

Plain-English summary

AvKARE, Inc. is recalling 19,623 bottles of AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets, 90-count bottles. 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 product is distributed nationwide. The recall covers specific lots with expiration dates ranging from September 2018 to October 2019. The NDC for the product is 42291-888-90.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be discontinued and returned to the supplier or destroyed according to local regulations.

The recalled product

Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
Manufacturer
Avkare Incorporated
Category
Drug — Antihypertensive
Hazard
Affected units
19,623

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 (9)

  • Lots: 17308 Exp. 09/2018
  • 18158 Exp. 09/2018
  • 18539 Exp. 01/2019
  • 19021 Exp. 01/2019
  • 19225 Exp. 01/2019
  • 20033 Exp. 06/2019
  • 20290 Exp. 06/2019
  • 20565 Exp. 06/2019
  • 21369 Exp. 10/2019

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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