CLASS III Drug recall · Reported 23 Jun 2021 · FDA Enforcement Report
Ketamine HCl Injection Solution, 10 mg / (5 mg/mL) recalled
Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution, 10 mg / (5 mg/mL), distributed in South Carolina. The recall was initiated on 8 Jun 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0648-2021
- FDA event ID
- 88097
- Recalling firm
- Prisma Health Outsourcing Facility, Simpsonville, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Jun 2021
- FDA classified
- 2 Jul 2021
- Reported
- 23 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Jun 2021 | Recall initiated by company | |
| 23 Jun 2021 | Published in enforcement report | +15 days |
| 2 Jul 2021 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Exp. Date: Incorrect BUD.
Product as listed by the FDA
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
Where it was distributed
Distributed in South Carolina
Questions about this recall
Why was it recalled?
Labeling: Incorrect Exp. Date: Incorrect BUD.
Which lots are affected?
Lots: K10521042 and K20521043 Exp. 08/31/2021.
Where was it sold?
Distributed in South Carolina
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Ketamine recalls
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketamine Hydrochloride Injectable Solution, 50mg/ml recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |