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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
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