Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
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
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Drug: Ceftazidime Category: Eye Drops & Ophthalmic
- Recalling firm
- Edge Pharma, LLC
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0238-2021 · 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 Ceftazidime recalls
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Class II · Moderate risk
Ceftazidime Intravitreal
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Ceftazidime
Lack of Assurance of Sterility
Class I · High risk
Ceftazidime for Injection USP and Dextrose for Injection USP
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
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