Class II · Moderate risk Terminated
CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN…
Reason Lack of Assurance of Sterility
Is Carboplatin recalled?
8 FDA recalls mention Carboplatin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carboplatin.
Class I · High risk Terminated
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 Terminated
Carboplatin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
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…
Class II · Moderate risk Terminated
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reason Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Class I · High risk Completed
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC…
Reason Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the…
Class I · High risk Completed
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira…
Reason Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the…
Class III · Low risk Terminated
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose…
Reason Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class II · Moderate risk Terminated
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc…
Reason The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to…
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