🔍 RecallPedia

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Class I - Dangerous
💊 Drugs Recalled: July 17, 2018 A-S Medication Solutions Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249
  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:
A-S Medication Solutions LLC.
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:
ongoing

Product Information

Full Description:

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Product Codes/Lot Numbers:

Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1108-2018

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