Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for guidance. Notification method: Letter
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Vancomycin HCl injection is a vital antibiotic used in hospitals to treat severe bacterial infections. Healthcare providers often rely on its efficacy for patients with resistant infections.
The recall is due to a lack of assurance of sterility, which means the product may be contaminated. Contaminated injections can lead to severe infections if administered.
This recall is not part of a broader industry pattern.
Consumers must stop using this product immediately to avoid potential health risks. The recall underscores the importance of sterility in injectable medications.
Lot numbers are typically printed on the label or packaging of the injection.
Expect about 4-6 weeks for refunds or replacements after initiating contact.
Keep records of the product, including photos of the lot number and any correspondence with the manufacturer.
The recalled product is vancomycin HCl, 2 grams, added to 500 mL of 0.9% Sodium Chloride Injection. Model numbers include Lot # C274-000047611 (Exp Date: 10-Feb-26) and Lot # C274-000049633 (Exp Date: 12-May-26).
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