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D-0539-2025Class II

Mckesson Medical-Surgical Inc. Corporate Office

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Product type
Drug
Status
Ongoing
Report date
2025-07-30
Distribution
Within the U.S - OH, VA, FL.
Firm state
VA
Product quantity
2 Pre-filled syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations; potential temperature excursions due to transit delays

Product 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.

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →