Drug recall D-0538-2025

Class II Ongoing reported Jul 30, 2025

Product

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Reason for recall

CGMP Deviations; potential temperature excursions due to transit delays

Lots and codes

Lot: 1180924, Expiration date: 6/30/2027.

Recall details

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Quantity
6 Pre-filled syringes
Distribution
Within the U.S - OH, VA, FL.
Type
Voluntary: Firm initiated
Recall initiated
April 21, 2025

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