FDA 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

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2022-04-13

Report date

2022-06-15

Termination date

2023-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2022