FDA Drugs recall ·
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only… recall
- Recall number
- D-0538-2025
- Date
- (initiated April 21, 2025)
- Company / brand
- Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive, Richmond, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 Pre-filled syringes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Why was it recalled?
CGMP Deviations; potential temperature excursions due to transit delays
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 1180924, Expiration date: 6/30/2027.
Distribution
Within the U.S - OH, VA, FL.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0538-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.