Class II · Moderate risk Terminated
Endophth Kit
Reason Lack of Assurance of Sterility
Ceftazidime
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-0733-01
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0397-2022
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 Ceftazidime recalls
See all
Class II · Moderate risk Terminated
Ceftazidime Intravitreal
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Ongoing
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution
Reason 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 I · High risk Terminated
Ceftazidime for Injection USP and Dextrose for Injection USP
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Class II · Moderate risk Terminated
Ceftazidime Sterile Ophthalmic Solution for Injection…
Reason Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
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