Class II · Moderate risk Terminated
Ertapenem
Reason Lack of sterility assurance
Invanz
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1460-2014
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 Ertapenem recalls
See all
Class II · Moderate risk Terminated
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Reason Lack Of Processing Controls
Class II · Moderate risk Terminated
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Invanz
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Ertapenem various strength in normal saline bags
Reason Lack of sterility assurance.
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