# FDA recall D-0648-2021

> **Prisma Health Outsourcing Facility** · Class III · drug recall initiated 2021-06-08.

## Product

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681.  NDC: 73463-0100-01

## Reason for recall

Labeling: Incorrect Exp. Date: Incorrect BUD.

## Distribution

Distributed in South Carolina

## Key facts

- **Recall number:** D-0648-2021
- **Recalling firm:** Prisma Health Outsourcing Facility
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-08
- **Report date:** 2021-06-23
- **Termination date:** 2021-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Simpsonville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2021

## Citation

> AI Analytics. FDA recall D-0648-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0648-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*