Drug Enforcement D-0538-2025

CGMP Deviations; potential temperature excursions due to transit delays

Status

Ongoing

Classification

Class II

Report Date

July 30, 2025

Termination Date

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Product Information

Product description
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Product quantity
6 Pre-filled syringes
Reason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Within the U.S - OH, VA, FL.

Location & Firm

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0538-2025
Event ID
97110
Recall initiation date
April 21, 2025
Center classification date
July 21, 2025
Code info
Lot: 1180924, Expiration date: 6/30/2027.
More code info
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