The Recall Desk
HighFDA (Drugs)·D-1002-2022·Announced 2022-06-15

Bupivacaine HCl Injection Units Recalled Due to Temperature Abuse

McKesson Medical-Surgical is recalling Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. However, it involves a sterile injectable medication where potential contamination from temperature abuse presents a risk of harm even though no injuries have yet been reported, meeting the criterion for High severity.

Plain-English summary

Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL is being recalled by McKesson Medical-Surgical Inc. due to cGMP deviations related to temperature abuse. The affected product was manufactured by Auromedics Pharma LLC under NDC 55150-0171-10.

The recall involves 32 cartons, each containing 25 vials, distributed nationwide throughout the United States. Temperature exposure during manufacturing or distribution may have compromised product quality.

Healthcare providers and medical facilities that received this product should stop using it and contact McKesson Medical-Surgical for instructions on return or safe disposal. Patients who have received an injection of this product should consult with their healthcare provider with any concerns.

The recalled product

Product
Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable Anesthetic
Hazard
  • temperature-abuse
  • sterility-compromise

Distribution

Distributed nationwide across the United States.

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