CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan…
Reason Presence of Particulate Matter
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB; CARBOPLATIN 500 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 575 MG / 500 ML NS IVPB; CARBOPLATIN 307 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 766 MG / 500 ML NS IVPB; CARBOPLATIN 684 / 250 ML NACL 0.9% IVPB; CARBOPLATIN 260 MG / 100 ML D5W IVPB CARBOPLATIN 360 MG /100 ML NACL 0.9% IVPB; CARBOPLATIN 274 MG / 250 ML D5W IVPB; CARBOPLATIN 240 MG / 100 ML D5W IVPB; CARBOPLATIN 750 MG / 250 ML NS IVPB; CARBOPLATIN 260 MG / 250 ML NS IVPB; CARBOPLATIN 460 MG / 250 ML NS IVPB; CARBOPLATIN 175 MG / 250 ML NS IVPB; CARBOPLATIN 229.4 MG / 500 ML NS IVPB CARBOPLATIN 780 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 140 MG / 250 ML NS IVPB; CARBOPLATIN 408 MG / 500 ML NS IVPB CARBOPLATIN 847 MG / 250 ML D5W IVPB; CARBOPLATIN 560 MG / 250 ML D5W IVPB; CARBOPLATIN 180 MG / 250 ML NS IVPB; CARBOPLATIN 200 MG / 250 ML D5W IVPB; CARBOPLATIN 238 MG / 500 ML NS 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 Presence of Particulate Matter
Reason Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged…
Reason Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Reason Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the…
Reason Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the…
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