Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
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
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.
Reason CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations…
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Reason Superpotent Drug: High out of specification assay value results for potency.
Reason Superpotent Drug: High out of specification assay value results for potency.
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