US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 20, 2016 (10 years ago)

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

What was recalled

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02

Recalling firm
Pharmakon Pharmaceuticals, Inc.
NDC code
45183-0885-02
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1318-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Vancomycin recalls

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Class II · Moderate risk Ongoing

Vancomycin HCL

Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

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Class II · Moderate risk Ongoing

Vancomycin HCI

Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Fagron Compounding Services NDC 71266-5085-01 D-0441-2026
Class II · Moderate risk Ongoing

Vancomycin HCI

Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Fagron Compounding Services NDC 71266-5083-01 D-0440-2026
Class II · Moderate risk Ongoing

vancomycin HCl

Reason Lack of Assurance of Sterility

Fresenius Kabi Compounding, LLC NDC 71506-019-59 D-0337-2026
Class II · Moderate risk Ongoing

vancomycin HCl

Reason Lack of Assurance of Sterility

Fresenius Kabi Compounding, LLC NDC 71506-016-59 D-0336-2026