Prescription Thrombin Product Recalled for Temperature Storage Deviations
McKesson is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recalled product represents a risk-of-harm product used for hemostasis; products were subjected to temperature abuse during storage or distribution, constituting a cGMP deviation that may affect stability and efficacy. No illnesses or injuries have been reported, qualifying for Score 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling RECOTHROM (Thrombin Topical Recombinant), a prescription medication used for hemostasis (stopping bleeding). The recall encompasses 110 cartons, each containing a 5,000-unit vial with sterile sodium chloride diluent and applicator equipment, distributed nationwide. The product is manufactured by Baxter Healthcare Corporation.
The recall was initiated because products experienced temperature abuse during storage or distribution, constituting a current Good Manufacturing Practice (cGMP) deviation.
McKesson Medical-Surgical has notified customers in writing. Each notice includes the date the product was distributed and the dates when impacted inventory may have been shipped. Because McKesson cannot identify the specific lot number delivered to each individual customer, the distribution and shipment dates provided in the notifications are used to determine whether a customer received affected units.
The recalled product
- Product
- RECOTHROM (THROMBIN TOPICAL RECOMBINANT)
- Brand
- RECOTHROM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Hemostatic
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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