🔍 RecallPedia

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Class I - Dangerous
💊 Drugs Recalled: April 21, 2025 Mckesson Medical-Surgical Inc. Corporate Office Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot: 1178382, Expiration date: 3/31/2027
  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:
Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall:
CGMP Deviations; potential temperature excursions due to transit delays
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Product Codes/Lot Numbers:

Lot: 1178382, Expiration date: 3/31/2027

Distribution:

Distributed in: OH, VA, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0539-2025

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