Ketamine injection bags recalled over a lack of assurance of sterility
Fresenius Kabi Compounding is recalling 1,410 bags of Ketamine HCl injection over a lack of assurance of sterility.
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: Scored 3 under the risk-of-harm criterion: sterility cannot be assured for a product given intravenously, and no injuries are reported.
Plain-English summary
Ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, prepared by Fagron Sterile Services of Canton, Massachusetts, under NDC 71506-050-56, is being recalled by Fresenius Kabi Compounding, LLC.
The reason given in the enforcement record is a lack of assurance of sterility.
The record lists 1,410 bags from lots C274-000047883 (expiry 17-Feb-26) and C274-000048515 (expiry 22-Mar-26), among the lots recorded in the enforcement record. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Sterility that cannot be assured in a product given intravenously carries an infection risk. The record reports no injuries. Facilities should quarantine affected lots and follow the firm's instructions.
The recalled product
- Product
- ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Compounded injection
- Affected units
- 1,410
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 (10)
- Lot # C274-000047883
- Exp Date: 17-Feb-26
- Lot # C274-000048515
- Exp Date: 22-Mar-26
- Lot # C274-000048679
- Exp Date: 31-Mar-26
- Lot # C274-000049119
- Exp Date: 19-Apr-26
- Lot # C274-000049282
- Exp Date: 27-Apr-26
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fresenius Kabi Compounding, 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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