Serious riskFDA DrugClass II

Fagron Vancomycin HCL IV bags recalled for sterility and port defect risk

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.

From the FDA notice · Read the official notice ↗

What to do

  1. 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)
  2. Do not use affected bags; isolate and quarantine them immediately
  3. Contact your pharmacy or supplier for replacement product
  4. Report any use of recalled bags or adverse events to FDA MedWatch or Fagron

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
11,680 bags
Illnesses reported
None reported
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Classification
Class II
Recall number
D-0442-2026

In the FDA's words

Description
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 Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026. Distribution: Nationwide in the U.S.A. Affected quantity: 11,680 bags
Hazard
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

5 products in this recall

Fagron IV norepinephrine and vancomycin bags recalled for sterility concerns

Fagron Compounding Services is recalling five premixed IV bags in 0.9% sodium chloride: norepinephrine bitartrate (16 mg and 32 mg per 250 mL) and vancomycin (1 g, 1.25 g and 1.5 g per 250 mL). The bags were made by Fagron Sterile Services in Wichita, Kansas, and sold nationwide, and the company cannot assure they are sterile. A blue break-off part on the administration port could also detach. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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