Vancomycin Injection
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Compare with the code on your package — it is the most precise check available.
Drug: Vancomycin
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.