Key Takeaway

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 CAR by Infusion Options, Inc. was recalled on June 12, 2019. The hazard: Lack of Assurance of Sterility

FDA Drug Class II Terminated

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 CAR

Recalled: June 12, 2019 ~N/A units affected D-1756-2019

Description

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

Hazard / Reason

Lack of Assurance of Sterility

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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 CAR

Drugs

Company Information

Infusion Options, Inc.

Brooklyn, NY, United States

View all 76 recalls by Infusion Options, Inc. →

Distribution

NY only

Related Recalls

FDA Drug Class II

FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019
FDA Drug Class II

ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019
FDA Drug Class II

ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019
FDA Drug Class II

INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019
FDA Drug Class II

Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019
FDA Drug Class II

DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

June 12, 2019

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.