Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of an injectable medication due to lack of assurance of sterility. No illnesses or hospitalizations have been reported, making this a theoretical risk-of-harm situation without reported injury, which corresponds to a High severity rating per the rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), in 5 mL pre-filled syringes. The recall includes multiple lot numbers: KH1086A (Exp. 6/24/2022), KH2002B (Exp. 7/5/2022), KH2008B (Exp. 8/8/2022), and KH2012A (Exp. 8/23/2022). A total of 107,530 syringes have been distributed.
The manufacturer initiated this recall because it cannot assure that the affected products maintain sterility. This is a critical quality issue for injectable medications.
The affected products were distributed nationwide in the United States. Healthcare facilities and providers who have received these lots should immediately discontinue use and contact their pharmaceutical supplier for instructions on disposal or return of the affected syringes.
The recalled product
- 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, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- Affected units
- 107,530
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 (8)
- Lots: KH1086A
- Exp. 6/24/2022
- KH2002B
- Exp. 7/5/2022
- KH2008B
- Exp. 8/8/2022
- KH2012A
- Exp. 8/23/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
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