US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Ceftazidime Ophthalmic

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML 0.8 ML 1.2 ML 1.6 ML (25 DIFFERENT PRODUCTS)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1482-2012

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

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Class II · Moderate risk Terminated

Endophth Kit

Reason Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC D-0052-2024
Class II · Moderate risk Terminated

Ceftazidime Intravitreal

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0197-2023
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.

Pharmacy Plus, Inc. dba Vital Care Compounder D-0030-2023
Class II · Moderate risk Terminated

Ceftazidime

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0733-01 D-0397-2022