Mckesson Medical-Surgical Inc. Corporate Office: Drug Recall

Recall #D-1003-2022 · 04/13/2022

Class II: Risk

Recall Details

Recall Number: D-1003-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Status: Terminated
Date Initiated: 04/13/2022
Location: Richmond, VA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 cartons/2 ml single dose vials

Reason for Recall

cGMP deviations: Temperature abuse

Product Description

Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02

Distribution Pattern

USA nationwide.

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 →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.