Drug recall D-1082-2022

Class II Terminated reported Jun 15, 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