Recalls / Class II
Class IID-0333-2026
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
- Affected lot / code info
- Lot # C274-000049124, Exp Date: 28-Feb-26.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fresenius Kabi Compounding, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Dan Rd, N/A, Canton, Massachusetts 02021-2809
Distribution
- Quantity
- 1057 bags
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2026-02-05
- FDA classified
- 2026-02-13
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0333-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.