FDAFDA · Food and drugs·Recall number D-1082-2022
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
Published June 15, 2022 · Recall initiated: April 13, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Temperature abuse
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RECOTHROM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- USA nationwide.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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