Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Xylocaine + Epinephrine 2%, 20 mL multi-dose vials (25 count boxes) manufactured by Fresenius Kabi USA LLC due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. The recalled product was distributed nationwide in the United States, affecting 33 trays containing 25 vials per tray. The manufacturer has been unable to identify the specific lot numbers received by individual customers, but has provided distribution dates to customers to help identify potentially affected product based on when it was shipped to their facilities.
The recall notice does not specify what action affected consumers should take regarding recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 33 trays/25 vials per tray Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.