FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fagron Vancomycin HCL IV bags recalled for sterility and port defect risk
What this means
Fagron Compounding Services is recalling specific lots of Vancomycin HCL injections due to two safety concerns: the bags may not be sterile, and a blue plastic part on the administration port could detach during use. The recall affects over 11,600 bags distributed nationwide.
- Check if your facility has any of the affected lot numbers (C274-000050987, C274-000049425, C274-000050069, C274-000050346, C274-000050698, C274-000050699, or C274-000050775)
- Do not use affected bags; isolate and quarantine them immediately
- Contact your pharmacy or supplier for replacement product
- Report any use of recalled bags or adverse events to FDA MedWatch or Fagron
The agency's original wording
Hazard
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the U.S.A.
Affected count
11,680 bags
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Products
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0442-2026Want us to check the next one for you?
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