Fresenius Kabi Compounding Recalls Acyclovir Sodium Injection Due to Sterility Concerns
Fresenius Kabi Compounding, LLC has voluntarily recalled 1,057 bags of acyclovir sodium injection distributed nationwide due to a lack of assurance of sterility.
What Happened
Fresenius Kabi Compounding, LLC (operating as Fagron Sterile Services) has initiated a voluntary recall of acyclovir sodium added to 0.9% Sodium Chloride Injection. The recall was prompted by a lack of assurance of sterility for the affected lot, which could pose significant health risks to patients receiving the intravenous medication.
Which Products Are Affected
The recall involves specific bags of acyclovir sodium for intravenous use. The following details identify the affected product:
- Product Name: acyclovir sodium, 200 mg (200mg added to 100 mL), 0.9% Sodium Chloride Injection, USP
- Packaging: Single-Use Bag
- NDC: 71506-035-56
- Lot Number: C274-000049124
- Expiration Date: 28-Feb-26
- Quantity: 1,057 bags
- Distribution: Distributed nationwide across the United States.
What You Should Do
Healthcare providers and medical facilities should immediately inspect their inventory for the affected lot number (C274-000049124). Any units from this lot should be quarantined and not administered to patients. The firm initiated the recall via notification letters; facilities should follow the specific instructions provided in those communications for the return or disposal of the affected products.
Why This Matters
A lack of assurance of sterility in an intravenous drug is a serious safety concern. Contaminated products injected directly into the bloodstream can lead to severe infections, systemic illness, or other life-threatening medical complications.
Source
This information is based on official recall data provided by the FDA (Recall Number: D-0333-2026).
Source: FDA Official Notice