Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1435-2019 | 06-13-2019 | Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64 Package NDCs: 10019-651-64; 10019-655-06 | Failed Stability Specifications | Baxter Healthcare Corporation / 5940 bottles | Class II | Terminated |
| D-1801-2019 | 06-12-2019 | PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1765-2019 | 06-12-2019 | DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1766-2019 | 06-12-2019 | DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1783-2019 | 06-12-2019 | HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250 ML NS IVPB; HERCEPTIN 650 MG / 250 ML NS IVPB; HERCEPTIN 472 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1759-2019 | 06-12-2019 | 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 WITH Magnesium 1 G and Mannitol 12.5 G; Cisplatin 60 MG /250 ml 0.9% NACL Cisplatin 47 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 150 MG / 250 ml 0.9% NACL; Cisplatin 115 MG /250 ml NS IVPB; Cisplatin 80 MG QS 500 ml NS IVPB WITH Mannitol 12.5 G; Cisplatin 120 MG / 500 ML NS IVPB Cisplatin 157 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 43 MG QS 1000 ml 0.9% NACL WITH Mannitol 12.5 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1762-2019 | 06-12-2019 | Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1806-2019 | 06-12-2019 | PRESERVATIVE FREE 0.9% NACL 5 ML SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1791-2019 | 06-12-2019 | METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1799-2019 | 06-12-2019 | 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 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1795-2019 | 06-12-2019 | OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1787-2019 | 06-12-2019 | IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML D5W IVPB; IRINOTECAN 135 mg / 500 ml D5W IVPB; IRINOTECAN 265 MG / 500 ML D5W IVPB; IRINOTECAN 140 MG / 500 ml D5W IVPB; IRINOTECAN 195 mg / 500 ml D5W IVPB; IRINOTECAN 245 mg / 500 ml D5W IVPB; IRINOTECAN 130 MG / 500 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1750-2019 | 06-12-2019 | AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG/100 ML 0.9% NACL IVPB; AVASTIN 250 MG / 100 ML 0.9% NACL IVPB; AVASTIN 693.125 MG/100 ML 0.9% NACL IVPB; AVASTIN 1020 MG/100 ML NS IVPB; AVASTIN 811.875 MG/100 ML 0.9% NACL IVPB; AVASTIN 1006.25 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1778-2019 | 06-12-2019 | FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1767-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1812-2019 | 06-12-2019 | Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1756-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1796-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1802-2019 | 06-12-2019 | PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1786-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1454-2019 | 06-12-2019 | Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44 Package NDCs: 69097-363-44 | Defective Container; actuator may improperly function and affect dose delivery. | InvaGen Pharmaceuticals, Inc. / 1776 bottles | Class III | Terminated |
| D-1819-2019 | 06-12-2019 | FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1813-2019 | 06-12-2019 | SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1771-2019 | 06-12-2019 | 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 NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Duplicate Doxorubicin 45 MG / 22.5 ML IVP SYRINGE | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1772-2019 | 06-12-2019 | Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1747-2019 | 06-12-2019 | 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 EMTANSINE 230mg/250ml NS IV Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1792-2019 | 06-12-2019 | MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1777-2019 | 06-12-2019 | 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 Fluorouracil 5000 MG QS 101 ml 0.9% NACL; Fluorouracil 750 MG / 15 ML IVP Fluorouracil 4500 mg QS 100 ml NS CASS; Fluorouracil 4100 mg QS 100 ml NS CASS; Fluorouracil 690 mg / 13.8 ml IVP; Fluorouracil 2400 MG QS 96 ML NS IV; Fluorouracil 812 MG/16.24 ML IVP; Fluorouracil 4872 MG QS 240 ML NS PUMP; Fluorouracil 4200 mg QS 100 ml NS CASS; Fluorouracil 1110 MG QS 96 ml NS IVPB; Fluorouracil 370 MG/ 50 ML NS; Fluorouracil 620 MG/ 12.4 ML SYRINGE IVP; Fluorouracil 3160 MG QS 92 ML 0.9% NACL; Fluorouracil 1050 mg QS 92 ml NS IVPB; Fluorouracil 370 MG /100 ML NS IVPB; Fluorouracil 4080 MG QS 1000 ML NS IVPB; Fluorouracil 5 MG / 0.1 ML SYRINGE; Fluorouracil 5040 MG QS 101 ml NS CADD; Fluorouracil 4224 MG QS 100 ml NS CASS; Fluorouracil 700 MG / 14 ML IVP; Fluorouracil 3550 mg QS 92 ML 0.9% NACL IV; Fluorouracil 760 MG / 15.2 ML IVP; Fluorouracil 4560 MG QS 240 ML NS PUMP; Fluorouracil 796 MG / 15.92 MLIVP Fluorouracil 4776 MG QS 240 ML NS PUMP; Fluorouracil 930 MG QS 240 ML NS PUMP; Fluorouracil 730 MG / 14.6 ML IVP SYR; Fluorouracil 4400 MG QS 100 ml NS CADD; Fluorouracil 2430 MG QS 96 ml 0.9% NACL; Fluorouracil 4728 MG QS 100 ml NS CASS; Fluorouracil 3550 MG QS 92 ML 0.9% NACL Fluorouracil 588 MG / 11.76 ML IVP; Fluorouracil 3528 MG QS 240 ML NS PUMP; Fluorouracil 2520 mg QS 96 ml NS IVPB; Fluorouracil 790 MG / 15.8 ml IVP; Fluorouracil 4750 mg QS 97 ml 0.9% NACL IV; Fluorouracil 2660 MG QS 96 ml NS IVPB; Fluorouracil 720 MG/ 14.4 ML IVP; Fluorouracil 4370 mg QS 92 ml 0.9% NACL IV; Fluorouracil 3280 MG QS 92 ML 0.9% NACL; Fluorouracil 780 MG / 15.6 ML IVP; Fluorouracil 4660 MG QS 97 ml 0.9% NACL Fluorouracil 3620 MG QS 100 ml NS CASS; Fluorouracil 2370 MG QS 92 ML 0.9% NACL; Fluorouracil 800 MG / 16 ML IVP; Fluorouracil 4800 MG QS 101 ml NS CADD; Fluorouracil 4000 mg QS 92 ML 0.9% NACL IV; Fluorouracil 2480 MG QS 96 ML 0.9% NACL; Fluorouracil 688 MG / 13.76 ml IVP Fluorouracil 4128 MG QS 1000 ML D5W IVPB; Fluorouracil 6000 MG QS 250 ml NS CASS; Fluorouracil 672 MG / 13.44 ML IVP; Fluorouracil 4032 MG / 1000 ML D5W IVPB; Fluorouracil 894 MG / 17.88 ml IVP; Fluorouracil 400 MG / 50 ML NS IVPB; Fluorouracil 840 MG / 16.8 ml IVP; Fluorouracil 590 MG/ 11.8 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1805-2019 | 06-12-2019 | PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1748-2019 | 06-12-2019 | ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1807-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1788-2019 | 06-12-2019 | IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1793-2019 | 06-12-2019 | NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1753-2019 | 06-12-2019 | BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1789-2019 | 06-12-2019 | 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 D5W IVPB; LEUCOVORIN 420 MG / 50 ML D5W IVPB; LEUCOVORIN 700 MG / 250 ml D5W IVPB; LEUCOVORIN 592 mg / 250 ml D5W IVPB; LEUCOVORIN 760 mg / 250 ml D5W IVPB; LEUCOVORIN 796 MG / 250 ml D5W IVPB; LEUCOVORIN 730 MG / 250 ml D5W IVPB; LEUCOVORIN 324 mg / 50 ml NS IVPB; LEUCOVORIN 590 MG / 250 ml D5W IVPB; LEUCOVORIN 336 MG / 50 ml NS IVPB; LEUCOVORIN 398 MG/ 250 ml D5W IVPB; LEUCOVORIN 354 MG / 50 ml NS IVPB; LEUCOVORIN 720 MG / 250 ml D5W IVPB; LEUC; VORIN 328 mg / 50 ml NS IVPB; LEUCOVORIN 776 MG / 250 ml D5W IVPB; LEUCOVORIN 339 MG / 250 ml D5W IVPB; LEUCOVORIN 800 mg / 250 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml NS IVPB; LEUCOVORIN 688 MG in 250 ML D5W IVPB; LEUCOVORIN 350 MG / 250 ml NS IVPB; LEUCOVORIN 672 MG / 250 ml D5W IVPB; LEUCOVORIN 588 mg / 250 ml D5W IVPB; LEUCOVORIN 812 MG / 250 ML D5W IVPB; LEUCOVORIN 300 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1803-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1752-2019 | 06-12-2019 | BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG / 100 ML NS IVPB; BEVACIZUMAB 758 MG / 100 ML NS IVPB; BEVACIZUMAB 690 MG / 100 ML NS IVPB BEVACIZUMAB 599 MG/100 ml NS IVPB; BEVACIZUMAB 1113 MG / 100 ML NS IVPB; BEVACIZUMAB 660 MG /100 ml NS IVPB; BEVACIZUMAB 590 MG / 100 ML NS IVPB; BEVACIZUMAB 620 MG / 100 ML NS IVPB BEVACIZUMAB 800 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1773-2019 | 06-12-2019 | ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1808-2019 | 06-12-2019 | REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB; REMICADE 800 MG/250 ml 0.9% NACL IVPB REMICADE 600 MG / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1800-2019 | 06-12-2019 | PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1776-2019 | 06-12-2019 | Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; Etoposide 170 MG / 500 ml 0.9% NACL IVPB; Etoposide 152 MG / 500 ml 0.9% NACL IVPB; Etoposide 275 MG / 500 ml NS IVPB; Etoposide 270 MG / 500 ml NS IVPB; Etoposide 90 MG / 500 ml NS IVPB; Etoposide 160 MG / 500 ml NS IVPB; Etoposide 178 MG/ 500 ml 0.9% NACL IVPB; Etoposide 214 MG / 500 ml NS IVPB; Etoposide 290 MG / 500 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1797-2019 | 06-12-2019 | OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50 MG / 250 ML D5W IVPB; OXALIPLATIN 70 MG / 500 ML D5W IVPB; OXALIPLATIN 40 MG / 250 ML D5W IVPB; OXALIPLATIN 155 MG / 250 ML D5W IVPB; OXALIPLATIN 85 MG / 250 ML D5W IVPB OXALIPLATIN 146 MG / 250 ML D5W IVPB; OXALIPLATIN 246 MG / 500 ML D5W IVPB; OXALIPLATIN 143 MG / 250 ML D5W IVPB; OXALIPLATIN 65 MG / 500 ML D5W IVPB; OXALIPLATIN 80 MG / 500 ML D5W IVPB; OXALIPLATIN 100 MG / 250 ML D5W IVPB; OXALIPLATIN 150 MG / 250 ML D5W IVPB; OXALIPLATIN 125 MG / 250 ML D5W IVPB; OXALIPLATIN 170 MG / 250 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1758-2019 | 06-12-2019 | CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1769-2019 | 06-12-2019 | DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 150 MG / 250 ml NS IVPB; DOCETAXEL 137 mg / 250 ml 0.9% NACL IVPB; DOCETAXEL 130 MG/ 250 ml NS IVPB; DOCETAXEL 140 MG/ 250 ml NS IVPB; DOCETAXEL 144 MG/ 250 ML NS IVPB; DOCETAXEL 117 MG/ 250 ML NS IVPB; DOCETAXEL 30 mg / 250 ml D5W IVPB; DOCETAXEL 125 MG/ 250 ml NS IVPB; DOCETAXEL 135 MG / 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1751-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1761-2019 | 06-12-2019 | Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG / 250 ML NS IVPB; Cyclophosphamide 980 MG / 500 ML NS IVPB; Cyclophosphamide 580 mg / 500 ML NS IVPB; Cyclophosphamide 880 MG / 500 ML NS IVPB; Cyclophosphamide 501 MG / 250 ML NS IVPB; Cyclophosphamide 1163 MG / 50 ML NS IVPB Cyclophosphamide 1100 MG / 500 ML NS IVPB; Cyclophosphamide 1152 MG / 250 ML NS IVPB; Cyclophosphamide 1116 MG / 250 ML NS IVPB Cyclophosphamide 894 MG / 250 ML NS IVPB; Cyclophosphamide 1210 MG / 500 ML NS IVPB; Cyclophosphamide 1010 MG/ 500 ML NS IVPB Cyclophosphamide 1030 MG / 500 ML NS IVPB; Cyclophosphamide 500 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1817-2019 | 06-12-2019 | VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1814-2019 | 06-12-2019 | TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1768-2019 | 06-12-2019 | DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1775-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1810-2019 | 06-12-2019 | RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 1000 MG / 1000 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1764-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1770-2019 | 06-12-2019 | 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 SYRINGE; Doxorubicin 120 MG / 60 ML IVP SYRINGE; Doxorubicin 106 MG / 53 ML IVP SYRINGE; Doxorubicin 90 MG / 45 ML IVP SYRINGE; Doxorubicin 14 MG/500 ML NS IV WITH Vincristine 0.7 MG and Etoposide 70 MG; Doxorubicin 100 MG / 50 ML IVP SYRINGE; Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG; Doxorubicin 45 MG / 22.5 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1811-2019 | 06-12-2019 | RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1763-2019 | 06-12-2019 | DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1818-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1798-2019 | 06-12-2019 | 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 / 250 ML NS IVPB; PACLITAXEL 290 MG / 500 ML NS IVPB; PACLITAXEL 168 MG / 250 ML NS IVPB; PACLITAXEL 157 MG / 250 ML NS IVPB; PACLITAXEL 350 MG / 500 ML NS IVPB; PACLITAXEL 280 mg / 500 ML NS IVPB; PACLITAXEL 282 mg / 500 ML NS IVPB; PACLITAXEL 90 MG / 250 ML D5W IVPB; PACLITAXEL 255 MG / 500 ML NS IVPB; PACLITAXEL 100 MG / 250 ML NS IVPB; PACLITAXEL 80 MG / 250 ML D5W IVPB; PACLITAXEL 117 MG / 250 ML NS IVPB; PACLITAXEL 159 MG / 250 ML NS IVPB; PACLITAXEL 330 MG / 500 ML NS IVPB; PACLITAXEL135 MG / 250 ML NS IVPB; PACLITAXEL 200 MG / 500 ML NS IVPB; PACLITAXEL 150 MG / 250 ML NS IVPB; PACLITAXEL 130 MG / 250 ML NS IVPB; PACLITAXEL 144 MG / 250 ML NS IVPB; PACLITAXEL 300 MG / 500 ML NS IVPB; PACLITAXEL 120 MG / 250 ML NS IVPB; PACLITAXEL 140 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1780-2019 | 06-12-2019 | GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1745-2019 | 06-12-2019 | Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1785-2019 | 06-12-2019 | InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1782-2019 | 06-12-2019 | GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1794-2019 | 06-12-2019 | ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1754-2019 | 06-12-2019 | 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 SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1790-2019 | 06-12-2019 | METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE 98 MG / 3.92 ML IM SYR; METHOTREXATE 55 MG / 2.2 ML IVP; METHOTREXATE 59.5 MG / 2.38 ML IVP; METHOTREXATE 12 mg QS 6 ml 0.9% NACL; METHOTREXATE 150 MG / 50 ML NS IVPB; METHOTREXATE 112.5 MG/ 4.5 ML IM SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1779-2019 | 06-12-2019 | 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 Fluorouracil 5000 MG QS 101 ml 0.9% NACL Fluorouracil 750 MG / 15 ML IVP Fluorouracil 4500 mg QS 100 ml NS CASS Fluorouracil 4100 mg QS 100 ml NS CASS Fluorouracil 690 mg / 13.8 ml IVP Fluorouracil 2400 MG QS 96 ML NS IV Fluorouracil 812 MG/16.24 ML IVP Fluorouracil 4872 MG QS 240 ML NS PUMP Fluorouracil 4200 mg QS 100 ml NS CASS Fluorouracil 1110 MG QS 96 ml NS IVPB Fluorouracil 370 MG/ 50 ML NS Fluorouracil 620 MG/ 12.4 ML SYRINGE IVP Fluorouracil 3160 MG QS 92 ML 0.9% NACL Fluorouracil 1050 mg QS 92 ml NS IVPB Fluorouracil 370 MG /100 ML NS IVPB Fluorouracil 4080 MG QS 1000 ML NS IVPB Fluorouracil 5 MG / 0.1 ML SYRINGE Fluorouracil 5040 MG QS 101 ml NS CADD Fluorouracil 4224 MG QS 100 ml NS CASS Fluorouracil 700 MG / 14 ML IVP Fluorouracil 3550 mg QS 92 ML 0.9% NACL IV Fluorouracil 760 MG / 15.2 ML IVP Fluorouracil 4560 MG QS 240 ML NS PUMP Fluorouracil 796 MG / 15.92 MLIVP Fluorouracil 4776 MG QS 240 ML NS PUMP Fluorouracil 930 MG QS 240 ML NS PUMP Fluorouracil 730 MG / 14.6 ML IVP SYR Fluorouracil 4400 MG QS 100 ml NS CADD Fluorouracil 2430 MG QS 96 ml 0.9% NACL Fluorouracil 4728 MG QS 100 ml NS CASS Fluorouracil 3550 MG QS 92 ML 0.9% NACL Fluorouracil 588 MG / 11.76 ML IVP Fluorouracil 3528 MG QS 240 ML NS PUMP Fluorouracil 2520 mg QS 96 ml NS IVPB Fluorouracil 790 MG / 15.8 ml IVP Fluorouracil 4750 mg QS 97 ml 0.9% NACL IV Fluorouracil 2660 MG QS 96 ml NS IVPB Fluorouracil 720 MG/ 14.4 ML IVP Fluorouracil 4370 mg QS 92 ml 0.9% NACL IV Fluorouracil 3280 MG QS 92 ML 0.9% NACL Fluorouracil 780 MG / 15.6 ML IVP Fluorouracil 4660 MG QS 97 ml 0.9% NACL Fluorouracil 3620 MG QS 100 ml NS CASS Fluorouracil 2370 MG QS 92 ML 0.9% NACL Fluorouracil 800 MG / 16 ML IVP Fluorouracil 4800 MG QS 101 ml NS CADD Fluorouracil 4000 mg QS 92 ML 0.9% NACL IV Fluorouracil 2480 MG QS 96 ML 0.9% NACL Fluorouracil 688 MG / 13.76 ml IVP Fluorouracil 4128 MG QS 1000 ML D5W IVPB Fluorouracil 6000 MG QS 250 ml NS CASS Fluorouracil 672 MG / 13.44 ML IVP Fluorouracil 4032 MG / 1000 ML D5W IVPB Fluorouracil 894 MG / 17.88 ml IVP Fluorouracil 400 MG / 50 ML NS IVPB Fluorouracil 840 MG / 16.8 ml IVP Fluorouracil 590 MG/ 11.8 ML IVP | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1815-2019 | 06-12-2019 | TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG / 250 ML NS IVPB; TRASTUZUMAB 266 MG / 250 ML NS IVPB TRASTUZUMAB 323 MG / 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1816-2019 | 06-12-2019 | VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg / 0.68 ml SQ SYRINGE; VELCADE 3.5 mg / 1.4 ML SQ SYRINGE; VELCADE 2.2 mg / 0.88 ml SQ SYRINGE; VELCADE 2.33 MG/ 0.93 ML SUB-Q SYRINGE; VELCADE 2.4 MG/ 0.96 ML SUB-Q SYRINGE VELCADE 2.63 MG/ 1.052 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1749-2019 | 06-12-2019 | ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1804-2019 | 06-12-2019 | PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1774-2019 | 06-12-2019 | ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1755-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1746-2019 | 06-12-2019 | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1760-2019 | 06-12-2019 | 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 WITH Magnesium 1 G and Mannitol 12.5 G; Cisplatin 60 MG /250 ml 0.9% NACL Cisplatin 47 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 150 MG / 250 ml 0.9% NACL; Cisplatin 115 MG /250 ml NS IVPB; Cisplatin 80 MG QS 500 ml NS IVPB WITH Mannitol 12.5 G; Cisplatin 120 MG / 500 ML NS IVPB Cisplatin 157 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 43 MG QS 1000 ml 0.9% NACL WITH Mannitol 12.5 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1781-2019 | 06-12-2019 | 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 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1757-2019 | 06-12-2019 | CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1784-2019 | 06-12-2019 | IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1809-2019 | 06-12-2019 | 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 1000 MG QS 200 ml 0.9% NACL; RITUXAN 500 MG / 300 ml 0.9% NACL; RITUXAN 660 MG QS 660 ml 0.9% NACL; RITUXAN 770 MG QS 770 mL 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1744-2019 | 06-12-2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / 820 60 units/bag | Class II | Terminated |
| D-1410-2019 | 06-10-2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01 | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Preferred Pharmaceuticals, Inc / 192 4 oz bottles | Class II | Terminated |
| D-1488-2019 | 06-07-2019 | Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78 | Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite | PharMEDium Services, LLC / 28,140 syringes | Class I | Terminated |
| D-1392-2019 | 06-07-2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13 | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly. | Akorn Inc / 16,216 cartons | Class III | Terminated |
| D-1455-2019 | 06-06-2019 | LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / 2,924,000 tablets | Class II | Ongoing |
| D-1456-2019 | 06-06-2019 | LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / 2,943,000 tablets | Class II | Ongoing |
| D-1390-2019 | 06-05-2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 17,904 20-count units | Class II | Terminated |
| D-1409-2019 | 06-05-2019 | Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 124,512 bottles | Class II | Terminated |
| D-1388-2019 | 06-05-2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 17,136 20-count units | Class II | Terminated |
| D-1387-2019 | 06-05-2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 9528 30 count units | Class II | Terminated |
| D-1389-2019 | 06-05-2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 14,399 30-count units | Class II | Terminated |
| D-1408-2019 | 06-05-2019 | Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 17,664 bottles | Class II | Terminated |
| D-1407-2019 | 06-05-2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 202,068 bottles | Class II | Terminated |
| D-1340-2019 | 06-03-2019 | Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71 Package NDCs: 68462-711-71; 68462-711-88 | Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. | Glenmark Pharmaceuticals Inc., USA / 31,656 boxes | Class II | Terminated |
| D-1525-2019 | 05-31-2019 | Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 7653 bottles | Class II | Terminated |
| D-1523-2019 | 05-31-2019 | Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 3789 bottles | Class II | Terminated |
| D-1527-2019 | 05-31-2019 | Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 15435 bottles | Class II | Terminated |
| D-1524-2019 | 05-31-2019 | Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 3864 bottles | Class II | Terminated |
| D-1522-2019 | 05-31-2019 | Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 6165 bottles | Class II | Terminated |
| D-1520-2019 | 05-31-2019 | Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 8645 bottles | Class II | Terminated |
| D-1341-2019 | 05-31-2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12. | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. / 2118 bottles | Class II | Terminated |
| D-1342-2019 | 05-31-2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32. | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. / 2598 bottles | Class II | Terminated |
| D-1521-2019 | 05-31-2019 | Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 5107 bottles | Class II | Terminated |
