Medications & Supplements/Prescription Drugs

Prisma Health Outsourcing Facility: Ketamine HCl Injection Recalled for Incorrect Expiration Date

Agency Publication Date: July 2, 2021

Summary

Prisma Health Outsourcing Facility has recalled 109 syringes of Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL). This recall was issued because the labels on the syringes contain an incorrect expiration date and beyond-use date. If the medication is used past its actual stability period, it may not work as intended or could potentially undergo chemical changes that make it unsafe. These products were distributed to clinical settings in South Carolina.

Risk

The incorrect labeling may lead healthcare providers to use the medication after it has lost its potency or chemical stability. This could result in a patient receiving an ineffective dose of the drug during treatment.

What You Should Do

Check your medical supplies for Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL) syringes.
Identify if your syringes have the National Drug Code (NDC) 73463-0100-01 printed on the label.
Check for lot numbers K10521042 or K20521043 with a printed expiration date of 08/31/2021.
Contact your healthcare provider or pharmacist immediately for guidance if you have this medication or have recently received it.
Return any unused syringes from these specific lots to the pharmacy or facility where they were obtained for a refund.
Contact Prisma Health Outsourcing Facility at 1071 Holland Rd Ste 2, Simpsonville, South Carolina, for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Option 2: Other Action

Contact the manufacturer for instructions.

How to: Contact Prisma Health Outsourcing Facility for further instructions regarding the return of affected lots.

Affected Products

Product: Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL)

Model:

73463-0100-01

Lot Numbers:

K10521042 (Exp. 08/31/2021)

K20521043 (Exp. 08/31/2021)

Date Ranges: 08/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88097

Status: Resolved

Manufacturer: Prisma Health Outsourcing Facility

Sold By: Prisma Health Outsourcing Facility

Manufactured In: United States

Units Affected: 109 syringes

Distributed To: South Carolina

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL) syringes.

Identify if your syringes have the National Drug Code (NDC) 73463-0100-01 printed on the label.

Check for lot numbers K10521042 or K20521043 with a printed expiration date of 08/31/2021.

Contact your healthcare provider or pharmacist immediately for guidance if you have this medication or have recently received it.

Return any unused syringes from these specific lots to the pharmacy or facility where they were obtained for a refund.

Contact Prisma Health Outsourcing Facility at 1071 Holland Rd Ste 2, Simpsonville, South Carolina, for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.