# FDA recall D-1082-2022

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · drug recall initiated 2022-04-13.

## 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

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-1082-2022
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-13
- **Report date:** 2022-06-15
- **Termination date:** 2023-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2022

## Citation

> AI Analytics. FDA recall D-1082-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1082-2022. Source: US FDA. Licensed CC0.

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