FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi acyclovir sodium IV injection recalled for sterility concerns
What this means
Fresenius Kabi Compounding has recalled acyclovir sodium 200 mg IV injection bags because the manufacturer cannot guarantee the product is sterile. The affected bags were produced by Fagron Sterile Services and have lot number C274-000049124 with an expiration date of February 28, 2026. No infections or injuries have been reported so far.
- If you are a healthcare provider or facility, check your inventory for lot # C274-000049124 (expires 28-Feb-26).
- Do not administer affected bags; quarantine and return them to your supplier.
- Contact Fresenius Kabi or your pharmaceutical distributor with questions.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
1057 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2026Want us to check the next one for you?
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