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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1082-2022 |
| Event ID | 89646 |
| Brand | RECOTHROM |
| Generic Name | THROMBIN TOPICAL RECOMBINANT |
| Manufacturer | THROMBIN TOPICAL RECOMBINANT |
| Original Package? | 1 |
| Distribution | USA nationwide. |
| Quantity | 110 cartons/5000 units each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0338-0322 0338-0326 0338-0330 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Drug Application Number | BLA125248 |
| 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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