Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY…
Reason Lack of Assurance of Sterility
Is Cefuroxime recalled?
8 FDA recalls mention Cefuroxime. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefuroxime.
Class II · Moderate risk Ongoing
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Class II · Moderate risk Terminated
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only…
Reason Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk Terminated
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Reason Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis…
Class III · Low risk Terminated
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office…
Reason Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class II · Moderate risk Terminated
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded…
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Cefuroxime various strengths in normal saline bags
Reason Lack of sterility assurance.
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