Recothrom Thrombin Topical — Class II drug recall D-1082-2022
Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-06-15, distributed nationwide. cGMP deviations: Temperature abuse
| Recall number | D-1082-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-04-13 |
| Classified | 2022-06-09 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2023-11-30 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, temperature control |
| NDC | 00338-0322, 00338-0322-01, 00338-0324-01, 00338-0326, 00338-0326-01, 00338-0328-01, 00338-0330, 00338-0330-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1082-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.