FDAClass IIJune 8, 2022

Ketamine Hydrochloride Injection recall: Sterility Concern

Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only…

Why was Ketamine Hydrochloride Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: KH1086A, Exp. 6/24/2022; KH2002B, Exp. 7/5/2022; KH2008B, Exp. 8/8/2022; KH2012A, Exp. 8/23/2022

Product
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only…
Recalling firm
Nephron Sterile Compounding Center LLC
Quantity
107530 syringes
Distribution
Nationwide in the USA
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls