FDA recall D-0648-2021

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

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

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