🔍 RecallPedia

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

Class I - Dangerous
💊 Drugs Recalled: March 4, 2019 H J Harkins Company Inc Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
  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:
H J Harkins Company Inc dba Pharma Pac
Reason for Recall:
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
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 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

Product Codes/Lot Numbers:

Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1083-2019

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