Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Xylocaine + Epinephrine in two formulations: 1% solution in 20 mL vials (25-count boxes) and 50 mL vials (25-count boxes). The recall affects 76 trays containing 25 vials each and was distributed nationwide across the United States. The products are being recalled due to temperature abuse during storage or handling, which violates current good manufacturing practice (cGMP) requirements.
Because McKesson cannot identify which specific lot numbers were received by individual customers, the company is providing each affected customer with the distribution date and the dates when impacted product may have been shipped to them. The source document does not specify what actions affected consumers or healthcare providers should take regarding this recall.
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: 76 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.