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.
IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML D5W IVPB; IRINOTECAN 135 mg / 500 ml D5W IVPB; IRINOTECAN 265 MG / 500 ML D5W IVPB; IRINOTECAN 140 MG / 500 ml D5W IVPB; IRINOTECAN 195 mg / 500 ml D5W IVPB; IRINOTECAN 245 mg / 500 ml D5W IVPB; IRINOTECAN 130 MG / 500 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Drug: Irinotecan
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.
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Superpotent Drug: High out of specification assay value results for potency.
Superpotent Drug: High out of specification assay value results for potency.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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