Recalls / Class II

Class IID-1756-2019

Product

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

Affected lot / code info

All lots within expiry

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Infusion Options, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5924 13th Ave, N/A, Brooklyn, New York 11219-4934

Distribution

Quantity

N/A

Distribution pattern

NY only

Timeline

Recall initiated

2019-06-12

FDA classified

2019-08-15

Posted by FDA

2019-08-21

Terminated

2025-03-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1756-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.