Acyclovir injection bags recalled over a lack of assurance of sterility
Fresenius Kabi Compounding is recalling 1,057 bags of acyclovir sodium 200 mg in 100 mL sodium chloride 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
Acyclovir sodium, 200 mg added to 100 mL of 0.9% Sodium Chloride Injection, USP, for intravenous use, in a single-use bag, prepared by Fagron Sterile Services of Canton, Massachusetts, under NDC 71506-035-56, 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 1,057 bags from lot C274-000049124, expiry 28-Feb-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 the affected lot and follow the firm's instructions.
The recalled product
- Product
- acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Antiviral injection
- Affected units
- 1,057
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 # C274-000049124
- Exp Date: 28-Feb-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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