The Recall Desk
HighFDA (Drugs)·D-1099-2022·Announced 2022-06-15

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.

What this means for you

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
Category
Drug — Hemostatic Agent / Injectable
Hazard
  • manufacturing-deviation
  • temperature-abuse
  • product-stability

Distribution

Distributed nationwide across the United States.

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