Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label, Rx onl
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Recothrom Thrombin Topical (Recombinant), 5,000 units, distributed nationwide in the United States. The recall involves 110 cartons, each containing a 5,000-unit vial of Recothrom with a 5-milliliter prefilled diluent syringe. The product is being recalled due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during storage or handling.
McKesson Medical-Surgical is unable to identify which specific lot numbers were received by individual customers. The company has notified customers by letter with the distribution date and the date range when affected product may have been shipped to them. The source does not specify a remedy or recommended consumer action.
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: 110 cartons/5000 units each 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.