Class II · Moderate risk
Ertapenem (Invanz)
Lack of sterility assurance
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack Of Processing Controls
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Drug: Ertapenem
- Recalling firm
- Redline Pharmacy Solutions
- Origin
- NE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1009-2020 · 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 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag
Lack of Sterility Assurance.
Class II · Moderate risk
Invanz (ertapenem)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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 Redline Pharmacy Solutions
All 2020 recalls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
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