Recall
FDAHealthApril 21, 2025

Mckesson Medical-Surgical Inc. Corporate Office — EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 5

⚠️ CGMP Deviations; potential temperature excursions due to transit delays

Is this relevant to me?

Geography
OH, VA, FL
Source agency
FDA
Category
Health
Published
April 21, 2025

Within the U.S - OH, VA, FL.

What's affected?

Product
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.
Brand
EVENITY
Lot code
1178382

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2 Pre-filled syringes.

View original FDA notice →

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