Home / Recalls / Infusion Options, Inc. / D-1764-2019

D-1764-2019 Class II Terminated

Recalled by Infusion Options, Inc. — Brooklyn, NY

FDA drug recall D-1764-2019 was initiated by Infusion Options, Inc. on June 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated March 21, 2025). Affected quantity: N/A.

Recall Details

Product Type: Drugs
Report Date: August 21, 2019
Initiation Date: June 12, 2019
Termination Date: March 21, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

NY only

Code Information

All lots within expiry

Other recalls by Infusion Options, Inc.

D-1809-2019 Class II — RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RI (June 12, 2019)
D-1744-2019 Class II — Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusi (June 12, 2019)
D-1746-2019 Class II — Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, B (June 12, 2019)
D-1781-2019 Class II — Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; (June 12, 2019)
D-1757-2019 Class II — CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFIL (June 12, 2019)
D-1760-2019 Class II — Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0. (June 12, 2019)
D-1778-2019 Class II — FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the (June 12, 2019)
D-1772-2019 Class II — Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, I (June 12, 2019)
D-1792-2019 Class II — MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the A (June 12, 2019)
D-1784-2019 Class II — IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, (June 12, 2019)