June 2021 FDA Recall Drug by Prisma Health Outsourcing Facility
D-0648-2021 - Labeling

This Class III drug recall was voluntarily initiated by Prisma Health Outsourcing Facility on June 8, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distributed in South Carolina and the recall is currently terminated.

Recall Number: D-0648-2021

Reason for Recall
Labeling: Incorrect Exp. Date: Incorrect BUD.
Initiated
06-08-2021
Reported
06-23-2021
Quantity
109 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88097
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Prisma Health Outsourcing Facility
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in South Carolina
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-21-2021
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lots: K10521042 and K20521043 Exp. 08/31/2021.