Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
Ketamine HCl Injection Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect Exp. Date: Incorrect BUD.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
73463-0100-01
Compare with the code on your package — it is the most precise check available.
Drug: Ketamine
- Recalling firm
- Prisma Health Outsourcing Facility
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0648-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ketamine recalls
See all
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
Class III · Low risk
Ketamine Hydrochloride
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Other labeling / mix-up recalls from 2021
All labeling / mix-up recalls
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Labeling: Missing Label
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class II · Moderate risk
Moxifloxacin
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Product Mix-up
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