PlainRecalls
FDA Drug Moderate Class II Terminated

Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1001-2022

Product Description

Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
16 cartons/24 vials each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 16 cartons/24 vials each.
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-1001-2022.