Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020
  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:
Golden State Medical Supply Inc.
Reason for Recall:
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated

Product Codes/Lot Numbers:

GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020

Distribution:

Distributed in: IL, MI, MN, PA, TN, TX, US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1286-2019

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