Bupivacaine HCl Injection Recalled Due to Temperature Abuse Manufacturing Defect
Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.
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: This is an FDA Class II recall involving a manufacturing defect (temperature abuse) of an injectable pharmaceutical product. No illnesses or injuries are reported in the source text, making the hazard theoretical rather than confirmed. However, manufacturing integrity is critical for injectable products, warranting a High severity rating.
Plain-English summary
Bupivacaine HCl Injection, 0.25%, supplied in 50 mL multi-dose vials, is being recalled. The product (NDC 55150-0249-50) was manufactured by Auromedics Pharma LLC and distributed nationwide by McKesson Medical-Surgical Inc.
The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. Temperature abuse refers to exposure to improper temperatures during manufacturing or distribution of the product.
The affected product totals 34 cartons, each containing 25 vials. McKesson Medical-Surgical was unable to identify specific lot numbers distributed to individual customers; however, affected customers have been provided with the dates their shipments may have been affected.
Patients and healthcare providers who have received this product should consult with their healthcare provider regarding alternative treatment options.
The recalled product
- Product
- Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50
- 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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