← FDA ENFORCEMENT
D-0333-2026Class II

Fresenius Kabi Compounding, LLC

Recalling firm
Fresenius Kabi Compounding, LLC
Product type
Drug
Status
Ongoing
Report date
2026-02-18
Distribution
US Nationwide.
Firm state
MA
Product quantity
1057 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Lot # C274-000049124, Exp Date: 28-Feb-26.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.