PlainRecalls
FDA Drug Moderate Class II Terminated

Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

Reported: June 15, 2022 Initiated: April 13, 2022 #D-0998-2022

Product Description

Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
224 cartons/10 vials each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 224 cartons/10 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-0998-2022.