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
Reported: June 15, 2022 Initiated: April 13, 2022 #D-1082-2022
Product Description
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
Details
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Units Affected
- 110 cartons/5000 units each
- Distribution
- USA nationwide.
- Location
- Richmond, VA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 110 cartons/5000 units each.
Why was this product recalled? ▼
cGMP deviations: Temperature abuse
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1082-2022.
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