FDA Drug recall D-0648-2021
Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2…
- FDA Drug
- Class III
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class III recall of Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2… by Prisma Health Outsourcing Facility, citing labeling: Incorrect Exp. Date: Incorrect BUD.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0648-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-06-08 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Prisma Health Outsourcing Facility |
| Distribution | SC |
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
Labeling: Incorrect Exp. Date: Incorrect BUD.
Identifiers
| code_info | Lots: K10521042 and K20521043 Exp. 08/31/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.