PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1003-2022

Product Description

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

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
5 cartons/2 ml single dose vials
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 5 cartons/2 ml single dose vials.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1003-2022.