Xylocaine Lidocaine Injectable Anesthetic Recalled for Storage Temperature Abuse
McKesson Medical-Surgical is recalling Xylocaine injectable anesthetic nationwide due to temperature abuse during storage that may compromise medication stability 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: This FDA Class II recall involves a manufacturing deviation that may have compromised medication stability and sterility. Since no illnesses or injuries are reported in the source, the severity is capped at High per the rubric for Class II recalls without reported harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Xylocaine (lidocaine hydrochloride 2% with epinephrine bitartrate) injectable anesthetic vials nationwide. The recall affects multi-dose 20 mL vials distributed in boxes of 25, with approximately 33 boxes recalled in total.
The FDA has classified this as a Class II recall due to temperature abuse, a cGMP deviation. Temperature exposure during storage may have compromised the medication's chemical stability, potency, and the sterility of the multi-dose vial.
Distributors and healthcare providers who received this product have been sent individual recall letters identifying the specific distribution dates for their shipments. Facilities should consult their recall letter and contact McKesson Medical-Surgical for instructions on handling and replacement of affected product.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Anesthetic
- Hazard
- temperature-abuse
- potency-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (14)
- 0363323484576
- 0363323485016
- 0363323483036
- 0363323487072
- 0363323486013
- 0363323495091
- 0363323488079
- 0363323489021
- 0363323495046
- 0363323491017
- 0363323492045
- 0363323492090
- 0363323482015
- 0363323481018
Distribution
Distributed nationwide across the United States.
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