Home / Recalls / Infusion Options, Inc. / D-1781-2019

D-1781-2019 Class II Terminated

Recalled by Infusion Options, Inc. — Brooklyn, NY

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

Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 1748 MG / 250 ML NS IVPB; Gemcitabine 890 MG /250 ML NS IVPB Gemcitabine 2000 MG /250 ML 0.9% NACL IVPB; Gemcitabine 660 MG / 250 ML NS IVPB; Gemcitabine 1880 MG /250 ML NS IVPB; Gemcitabine 1180 MG / 250 ML NS IVPB; Gemcitabine 1400 MG / 250 ML NS IVPB Gemcitabine 1300 MG / 250 ML NS IVPB; Gemcitabine 1406 MG /250 ML NS IVPB; Gemcitabine 1672 MG / 250 ML NS IVPB; Gemcitabine 2050 MG / 250 ML NS IVPB; Gemcitabine 1260 MG / 250 ML NS IVPB; Gemcitabine 1710 MG / 250 ML NS IVPB; Gemcitabine 1320 MG / 250 ML NS IVPB; Gemcitabine 1200 MG /250 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-1784-2019 Class II — IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, (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-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-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-1795-2019 Class II — OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Op (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-1803-2019 Class II — PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMET (June 12, 2019)
D-1773-2019 Class II — ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave (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)