Class II · Moderate risk
Ertapenem (Invanz)
Lack of sterility assurance
Invanz (ertapenem)
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
Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Drug: Ertapenem
- Recalling firm
- Sentara Enterprises
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0628-2016 · 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 Ertapenem recalls
See all
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag
Lack of Sterility Assurance.
Class II · Moderate risk
Ertapenem various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Invanz (ertapenem)
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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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