Drug recall: Thrombin JMI injection kits due to manufacturing temperature deviation
McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.
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: This is an FDA Class II recall involving a manufacturing process deviation that may affect product quality and efficacy. While no illnesses or injuries have been reported, this represents a risk-of-harm to patients relying on this hemostatic agent for proper blood clotting control.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling 157 kits of Thrombin JMI Vial 5,000IU with diluent, manufactured by Pfizer (NDC 60793-215-05). This prescription hemostatic agent was distributed nationwide across the United States.
The recall is due to cGMP deviations related to temperature abuse during manufacturing. Temperature exposure may have compromised the product's quality, stability, or effectiveness.
McKesson Medical-Surgical is unable to identify the specific lot numbers associated with particular customers. Facilities and healthcare providers who received this product should consult their distribution records and contact McKesson Medical-Surgical directly for further guidance.
The recalled product
- Product
- Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 157
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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