FDA (Drugs) recall action 83136

Infusion Options, Inc. recalled 76 products on 2019-08-21

The FDA (Drugs) publishes a recall like this one as 76 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 76 pages.

Products: 76
Announced: 2019-08-21
Critical: 0
Units: —

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

51–75 of 76

SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Methylprednisolone Due to Sterility Concerns
Infusion Options, Inc. is recalling Methylprednisolone 10 mg/0.16 mL IVP products due to a lack of assurance of sterility. The recall is limited to New York.
Product
METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific trastuzumab and emtansine infusion products in New York due to a lack of assurance of sterility.
Product
ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Vincristine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific vincristine infusion products in New York due to a lack of assurance of sterility.
Product
VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Eribulin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific Eribulin infusion products in New York due to a lack of assurance of sterility.
Product
ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBULIN 1.89 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Entyvio Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.
Product
ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Ferric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was distributed in New York.
Product
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV products in New York due to a lack of assurance of sterility.
Product
PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Doxorubicin Syringes Due to Sterility Concerns
Infusion Options, Inc. is recalling various Doxorubicin IV syringes in New York due to a lack of assurance of sterility.
Product
Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG / 46.5 ML IV SYRINGE; Doxorubicin 112 MG / 56 ML IVP SYRINGE; Doxorubicin 50 MG / 25 ML IVP…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific Ramucirumab infusion products in New York due to a lack of assurance of sterility.
Product
RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Doxorubicin Liposomal Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions in New York due to a lack of assurance of sterility.
Product
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Paclitaxel Albumin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Paclitaxel Albumin infusions in New York due to a lack of assurance of sterility.
Product
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB PACLITAXEL ALBUMIN 165 mg / 100 ml NS IVPB; PACLITAXEL ALBUMIN 150 mg /100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Paclitaxel Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Paclitaxel infusion bags in New York due to a lack of assurance of sterility.
Product
PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Rituxan Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Rituxan infusion bags in New York due to a lack of assurance of sterility.
Product
RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN…
Category
Distribution
1 state
HighFDA (Drugs)··2019-08-21
Infusion Options Recalls Azacitidine Syringes Due to Sterility Concerns
Infusion Options, Inc. is recalling Azacitidine syringes in New York due to a lack of assurance of sterility.
Product
AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Pemetrexed infusion products in New York due to a lack of assurance of sterility.
Product
PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Atezolizumab Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Atezolizumab 1200 mg/250 mL in New York due to a lack of assurance of sterility.
Product
ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Fluorouracil infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Product
Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; Fluorouracil 3920 MG QS 92 ML 0.9% NACL; Fluorouracil 3760 mg QS 100 ml NS CASS; Fluorouracil 4000 MG QS 92 ml 0.9% NACL; Fluorouracil 3140 MG QS 240 ML NS PUMP; Fluorouracil 2400 MG QS 96 ML 0.9% NACL…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infliximab Infusion Bags Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Infliximab 300 mg/250 mL infusion bags due to a lack of assurance of sterility. The recall affects New York.
Product
InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls ORENCIA Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling ORENCIA 750 mg IV infusions in New York due to a lack of assurance of sterility.
Product
ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.
Product
LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Dexamethasone Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific dexamethasone infusion products in New York due to a lack of assurance of sterility.
Product
DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 MG / 50 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Bortezomib Syringes Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Bortezomib subcutaneous syringes in New York due to a lack of assurance of sterility.
Product
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB 2.7 mg / 1.08 ML SQ SYRINGE; BORTEZOMIB 1.45 mg / 0.58 ml SQ SYRINGE; BORTEZOMIB 2.25 mg (0.9 ML) SQ SYRINGE; BORTEZOMIB 1.98 mg / 0.79 ml SQ…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Panitumumab Infusion Recalled Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.
Product
PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Product
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS…
Category
Distribution
1 state
SevereFDA (Drugs)··2019-08-21
Infusion Options Recalls Calcium Glucunate IV Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling Calcium Glucunate 1 gm/100 mL IV bags in New York due to a lack of assurance of sterility.
Product
CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Distribution
1 state