Bupivacaine Injectable Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection vials (NDC 55150-0170-30) distributed nationwide due to temperature abuse during manufacturing that may affect product quality. No illnesses have been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing control violation (temperature abuse) that may affect product quality and sterility, but no actual harm has been documented, placing this recall in the Moderate category.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Bupivacaine HCl Injection (0.5%, 30 mL vials, NDC 55150-0170-30) distributed nationwide. The recall is due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process.
Bupivacaine is a prescription local anesthetic used by healthcare providers for pain management. Temperature excursions during manufacturing may affect the quality and sterility of the product. The recalled shipment consists of 4 cartons containing 25 vials each.
Because McKesson Medical-Surgical cannot identify the specific lot numbers distributed to individual healthcare facilities, the company is working with affected distributors and healthcare providers to remove product from circulation. Healthcare providers who received this product should stop using it and contact their supplier for return instructions.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
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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