FDA Recalls Xylocaine MPF Injectable Due to Temperature Storage Deviations
McKesson Medical-Surgical is recalling Xylocaine MPF (lidocaine and epinephrine injection) nationwide due to temperature abuse during storage that could affect drug quality. Healthcare providers should discontinue use and contact their supplier.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—temperature abuse affecting drug integrity—is a risk-of-harm situation where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL single dose vials (5-count boxes) distributed nationwide. The recall was initiated due to cGMP deviations involving temperature abuse during storage, which could compromise drug integrity and efficacy.
The affected product is an injectable anesthetic used in healthcare settings. Temperature exposure of pharmaceutical products can reduce their stability and effectiveness. McKesson Medical-Surgical notes that specific lot numbers cannot be identified for individual customers; each customer has been provided with the distribution dates of potentially affected product.
Healthcare facilities, distributors, and pharmacies that received the product are advised to discontinue use and contact McKesson Medical-Surgical for guidance on return or replacement. Patients who have received injections of this product should consult with their healthcare provider with any concerns about their care.
The recalled product
- Product
- Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable / Anesthetic
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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