Bupivacaine Hydrochloride Injection Recalled Due to Manufacturing Temperature Deviations
McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.
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: The recall is classified as FDA Class II for GMP deviations involving temperature abuse of a sterile injectable drug. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity score.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride, USP 0.5% (5 mg/mL) injections that were distributed nationwide. The product is a prescription local anesthetic used for epidural, infiltration, intracaudal, and perineural routes.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations involving temperature abuse during manufacturing or handling. Temperature exposure of injectable pharmaceuticals can compromise the chemical stability and sterility of the product, potentially affecting its safety and efficacy for patients receiving the injection.
This recall affects healthcare facilities and medical practitioners who received the affected product nationwide.
Healthcare providers should discontinue use of the recalled product immediately and contact their supplier for replacement stock or further instructions. Patients who have received injections using this product should contact their healthcare provider if they have any concerns.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- gmp-deviation
Distribution
Distributed nationwide across the United States.
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