Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Ceftazidime Intravitreal
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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 Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Drug: Ceftazidime
- Recalling firm
- Pharmacy Innovations
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0197-2023 · 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
See all
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.
Class II · Moderate risk
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Other recalls by Pharmacy Innovations
All 2022 recalls
Class II · Moderate risk
Voriconazole 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vitamin D3-Aqueous- 10
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vancomycin Fortified 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tobramycin Fortified 15mg/Ml Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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