The Recall Desk
HighFDA (Drugs)·D-0998-2022·Announced 2022-06-15

Bupivacaine Hydrochloride Injection Recalled for Temperature Storage Deviations

McKesson Medical-Surgical is recalling Bupivacaine Hydrochloride Injection due to temperature abuse during storage that may have compromised product sterility. The recall affects 224 cartons 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: FDA Class II temperature-abuse deviation of a preservative-free injectable product presents a potential sterility compromise. This constitutes a risk-of-harm product category where no illnesses or injuries have been reported in the source.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride Injection, 0.5% concentration in 10mL single-dose vials (preservative free). A total of 224 cartons have been distributed nationwide to healthcare facilities and distributors.

The recall was initiated due to temperature abuse deviations from Current Good Manufacturing Practice (cGMP) standards during product storage and shipment. Temperature fluctuations can compromise the sterility assurance of preservative-free injectable products, which rely entirely on aseptic manufacturing and handling to prevent contamination.

Affected customers have been notified by McKesson Medical-Surgical Inc. with specific information about distribution dates and impacted product shipment dates. Healthcare facilities and distributors should follow the recall instructions provided by the recalling firm.

The recalled product

Product
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
Brand
BUPIVACAINE HYDROCHLORIDE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable / Sterile Preparation
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (8)

  • 0355150170302
  • 0355150250509
  • 0355150249503
  • 0355150168309
  • 0355150169108
  • 0355150167104
  • 0355150172306
  • 0355150171101

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

Related recalls

Same brand · BUPIVACAINE HYDROCHLORIDE

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Same hazard · temperature abuse

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