🔍 RecallPedia

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

Class I - Dangerous
💊 Drugs Recalled: July 18, 2018 Avkare Incorporated Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 17349 Exp. 08/2018; 18395 Exp. 08/2018; 19221 Exp. 06/2019; 20029 Exp. 06/2019; 20158 Exp. 07/2019; 20843 Exp. 07/2019; 21411 Exp. 09/2019.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Avkare Incorporated
Reason for Recall:
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

Product Codes/Lot Numbers:

Lots: 17349 Exp. 08/2018; 18395 Exp. 08/2018; 19221 Exp. 06/2019; 20029 Exp. 06/2019; 20158 Exp. 07/2019; 20843 Exp. 07/2019; 21411 Exp. 09/2019.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1173-2018

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