The Recall Desk
HighFDA (Drugs)·D-1261-2022·Announced 2022-07-27

Ketamine HCl Injection Recalled for Lack of Sterility Assurance

Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of injectable medication for lack of sterility assurance. No illnesses or injuries reported. While sterility assurance is critical for injectable safety, absence of confirmed contamination or adverse events justifies a High rating.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Ketamine HCl Injection, USP, 50 mg/1 mL in pre-filled syringes due to lack of assurance of sterility. The recall affects approximately 47,905 syringes that were distributed nationwide.

The affected lot numbers are: KH2009A (Exp. 8/16/2022), KH2011A (Exp. 8/24/2022), KH2013A (Exp. 8/28/2022), KH2014A (Exp. 9/9/2022), KH2018A (Exp. 10/7/2022), and KH2020A (Exp. 10/18/2022).

Healthcare providers and facilities using this product should contact Nephron Sterile Compounding Center LLC or the FDA for guidance on the proper handling and disposition of the recalled syringes.

The recalled product

Product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 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: 69374-511-01
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Medication
Hazard
Affected units
47,905

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 (12)

  • Lots: KH2009A
  • Exp. 8/16/2022
  • KH2011A
  • Exp. 8/24/2022
  • KH2013A
  • Exp. 8/28/2022
  • KH2014A
  • Exp. 9/9/2022
  • KH2018A
  • Exp. 10/7/2022
  • KH2020A
  • Exp. 10/18/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility assurance

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