Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
Ketamine HCl Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Affected NDC
69374-0982-55
Compare with the code on your package — it is the most precise check available.
Drug: Ketamine
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1259-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 recalls by Nephron Sterile Compounding Center LLC
All 2022 recalls
Class II · Moderate risk
Sodium Chloride Injection 9%
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
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