Product Safety Recalls

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Recall D-1082-2022

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

Recall D-1082-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1082-2022
Event ID89646
BrandRECOTHROM
Generic NameTHROMBIN TOPICAL RECOMBINANT
ManufacturerTHROMBIN TOPICAL RECOMBINANT
Original Package?1
DistributionUSA nationwide.
Quantity110 cartons/5000 units each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0338-0322 0338-0326 0338-0330
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Drug Application NumberBLA125248
Structured Product Labeling (SPL ID)8814eb73-89ef-4f8c-9c3b-bd330672944a
Structured Product Labeling (SPL Set ID)54885644-e51e-4263-aadb-366abaeb56a3
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