Bupivacaine HCl Injection Recalled for Temperature Control Deviation
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.
What this means for you
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 for manufacturing process deviation with no reported illnesses or injuries. The hazard is related to manufacturing controls (temperature control) rather than direct product safety or contamination, making it a precautionary quality-related recall.
Plain-English summary
The injectable anesthetic Bupivacaine HCl Injection, produced by Auromedics Pharma LLC and distributed by McKesson Medical-Surgical Inc., is being recalled due to cGMP (current Good Manufacturing Practice) deviations related to temperature abuse during manufacturing. The recalled product is supplied in 0.50% concentration in 50 mL multi-dose vials (NDC 55150-0250-50).
The product was distributed throughout the United States. McKesson Medical-Surgical states that it cannot identify the specific lot number received by each facility; however, each customer who received recalled product has been notified with information about the distribution and shipping dates of the affected shipments.
No illnesses or injuries have been reported in connection with this recall. Customers who have received this product should contact McKesson Medical-Surgical Inc. or their supplier for specific lot number information and recall return instructions.
The recalled product
- Product
- Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable / Anesthetic
- Hazard
- cgmp-violation
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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