Drug recall D-1082-2022
Product
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 only, MFG: Baxter, NDC# 0338-0322-01
Reason for recall
cGMP deviations: Temperature abuse
Lots and codes
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.
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Quantity
- 110 cartons/5000 units each
- Distribution
- USA nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2022
- Terminated
- November 30, 2023
Related products
- Recothrom – drug information
- NDC 0338-0330 Recothrom · · Baxter Healthcare Corporation
- NDC 0338-0326 Recothrom · · Baxter Healthcare Corporation
- NDC 0338-0322 Recothrom · · Baxter Healthcare Corporation