Moderate riskFDA DrugClass II

Fagron vancomycin saline injection bags recalled for sterility risk

Fagron Sterile Services is recalling certain lots of Vancomycin HCl added to 0.9% Sodium Chloride Injection bags (NDC 71266-5085-01). The bags may not be sterile, and a blue break-off part on the administration port could detach. About 16,130 bags were distributed nationwide, and no injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the lot number and expiration date on any vancomycin saline bag against the recall list.
  2. Do not use bags from the listed lots. Contact your pharmacy or healthcare provider about replacement or disposal.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
16,130 bags
Illnesses reported
None reported
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Classification
Class II
Recall number
D-0441-2026

In the FDA's words

Description
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026. Distribution: Nationwide in the U.S.A. Affected quantity: 16,130 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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