The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0648-2021·Announced 2021-06-23

Ketamine HCl Injection Solution Recalled for Labeling and Expiration Date Errors

Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution (10 mg / 2 mL) distributed in South Carolina due to incorrect expiration dates and incorrect Beyond Use Dates (BUD) on the labeling.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving labeling errors (incorrect expiration date and BUD). The source text does not report any illnesses, injuries, or deaths. Per the rubric, FDA Class III recalls are typically scored 1 or 2, and labeling errors without reported adverse events fall under the "Moderate" category as minor labeling errors.

Plain-English summary

Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, with NDC 73463-0100-01, manufactured by Prisma Health Outsourcing Facility in Simpsonville, South Carolina. The recall affects 109 syringes from lots K10521042 and K20521043 with an expiration date of 08/31/2021. The product was distributed in South Carolina.

The recall was initiated due to incorrect expiration dates and incorrect Beyond Use Dates (BUD) printed on the product labeling. Inaccurate expiration and BUD dates may prevent healthcare providers from properly assessing product stability and safety.

Healthcare providers and patients who have received this product should contact their pharmacy or healthcare facility for guidance. Patients should not use this product if they possess it and should return it to their healthcare provider or pharmacy.

The recalled product

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
Manufacturer
Prisma Health Outsourcing Facility
Category
Drug — Compounded Injection
Hazard
Affected units
109

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lots: K10521042 and K20521043 Exp. 08/31/2021.

Distribution

Distributed in 1 state:

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