PlainRecalls
FDA Drug Moderate Class II Terminated

Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1002-2022

Product Description

Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
32 cartons/25 vials each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 32 cartons/25 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-1002-2022.