Vancomycin injection bags recalled over a lack of assurance of sterility
Fresenius Kabi Compounding is recalling 1,578 bags of Vancomycin HCl injection over a lack of assurance of sterility.
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: 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
Vancomycin HCl, 1.5 grams, added to 500 mL of 0.9% Sodium Chloride Injection, USP, prepared by Fagron Sterile Services of Canton, Massachusetts, under NDC 71506-016-59, 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 1,578 bags from lot C274-000049628, expiry 3-May-26. 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
- vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Compounded injection
- Affected units
- 1,578
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)
- Lot # C274-000049628
- Exp Date: 3-May-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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