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Class III: unlikely to cause harmTerminated

Prisma Health Outsourcing Facility Ketamine HCl Injection Solution Recall

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma…

Prisma Health Outsourcing Facility · Simpsonville, SC

Risk level
Class III
Reported by FDA
Jun 23, 2021
Recall ID
D-0648-2021
Check your lot numberHow we source this data

Summary

Prisma Health Outsourcing Facility recalled Ketamine HCl Injection Solution starting Jun 8, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0648-2021 on Jun 23, 2021. Reason: Labeling: Incorrect Exp. Date: Incorrect BUD. Status: Terminated.

Why it was recalled

Labeling: Incorrect Exp. Date: Incorrect BUD.

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Distributed in South Carolina

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0648-2021
Classification
Class III
Status
Terminated
Recall initiated
Jun 8, 2021
FDA report date
Jun 23, 2021
Quantity
109 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Prisma Health Outsourcing Facility

Original FDA data

Every field from FDA enforcement report D-0648-2021, exactly as published.

Show all FDA fields
City
Simpsonville
State
SC
Status
Terminated
Country
United States
Event ID
88097
Address
1071 Holland Rd Ste 2
Code information
Lots: K10521042 and K20521043 Exp. 08/31/2021.
Postal code
29681-5709
Report date
Jun 23, 2021
Product type
Drugs
Recall number
D-0648-2021
Classification
Class III
Recalling firm
Prisma Health Outsourcing Facility
Product quantity
109 syringes
Termination date
Sep 21, 2021
Reason for recall
Labeling: Incorrect Exp. Date: Incorrect BUD.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed in South Carolina
Recall initiation date
Jun 8, 2021
Initial firm notification
E-Mail
Center classification date
Jul 2, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0648-2021, published Jun 23, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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