Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Cefepime
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Drug: Cefepime
- Recalling firm
- Sentara Enterprises
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0629-2016 · FDA notice
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.
Other Cefepime recalls
See all
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime for Injection
Lack of Assurance of Sterility
Other recalls by Sentara Enterprises
All 2015 recalls
Class II · Moderate risk
MYCAMINE (micafungin sodium)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Dextrose-5% Lactated Ringers
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Tobramycin 120MG
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Gentamicin
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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