Mckesson Medical-Surgical Inc. Corporate Office: Drug Recall

Recall Details

Recall Number

D-0538-2025

Classification

Class II

Product Type

Drug

Recalling Firm

Mckesson Medical-Surgical Inc. Corporate Office

Status

Ongoing

Date Initiated

04/21/2025

Location

Richmond, VA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6 Pre-filled syringes

Reason for Recall

CGMP Deviations; potential temperature excursions due to transit delays

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

Distribution Pattern

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

Other Recalls by Mckesson Medical-Surgical Inc. Corporate Office

• Class II: Risk 07/30/2025
  Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
• Class II: Risk 04/25/2025
  Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
• Class II: Risk 04/25/2025
  Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
• Class II: Risk 04/24/2025
  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
• Class II: Risk 04/24/2025
  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

View all recalls by Mckesson Medical-Surgical Inc. Corporate Office →