Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 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 drug recall for a sterility assurance failure. The hazard involves an injectable medication where sterility is critical to safety. The risk profile qualifies as 'High' under the rubric for risk-of-harm products.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Ketamine HCl Injection, USP 30 mg/3 mL pre-filled syringes. The recall affects approximately 30,745 syringes with Lot KH2002A (expiration 7/5/2022) distributed nationwide in the USA.
The recall was issued by the FDA due to lack of assurance of sterility in the recalled syringes. Ketamine HCl Injection is a prescription injectable medication that requires reliable sterilization for safe use.
Healthcare providers and institutions who have received this product should discontinue use and contact Nephron Sterile Compounding Center for information on return and replacement procedures.
The recalled product
- Product
- Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 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: 69374-982-33
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 30,745
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 (2)
- Lots: KH2002A
- Exp. 7/5/2022
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.
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