Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
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.
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Drug: Cefuroxime
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.
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.
Lack of Assurance of Sterility
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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