US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2013 (13 years ago)

Vancomycin Opth Soln 25mg/ml PF

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

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

What was recalled

Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,

Recalling firm
Nora Apothecary and Alternative Therapies, Inc.
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-467-2013

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

Fagron Compounding Services NDC 71266-5082-01 D-0442-2026
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 71266-5085-01 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