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

FDA recall notice · announced June 23, 2021 · Prisma Health Outsourcing Facility

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Distributed in South Carolina
Lot/code information: Lots: K10521042 and K20521043 Exp. 08/31/2021.
Quantity: 109 syringes
Status: Terminated
Products in this recall event:
- 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 (D-0648-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.