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Recall Observatory FDA recall evidence

Drug 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

D-0333-2026

February 05, 2026

Class II

Product summary

Firm
Fresenius Kabi Compounding, LLC
Event
Event 98391
Status
Ongoing
Classification
Class II
Quantity
1057 bags
Official record key
drug-enforcement:D-0333-2026

Official wording

Reason: Lack of Assurance of Sterility

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

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility