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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Infusion Options, Inc.: Various IV Solutions Recalled for Lack of Assurance of Sterility

Agency Publication Date: August 15, 2019
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Summary

Infusion Options, Inc. is recalling 820 units of Oxytocin 60 units/1000 mL and dozens of other compounded intravenous (IV) solutions, including cancer treatments and electrolyte replacements. These medications were recalled because they may not be sterile, which could lead to life-threatening infections if administered. The affected products were distributed exclusively in New York and were produced under conditions that cannot guarantee the safety of the injectable medication.

Risk

The lack of sterility assurance means these medications could contain bacteria or fungi. Injecting a non-sterile product directly into the bloodstream or under the skin can cause severe, life-threatening infections such as sepsis or meningitis.

What You Should Do

  1. Check the labels of any IV bags or syringes provided by Infusion Options, Inc. for the manufacturer address: 5924 13th Ave, Brooklyn, NY 11219.
  2. Review the recall numbers (D-1744-2019 through D-1819-2019) to identify if your specific medication is included, such as Oxytocin, Abraxane, Avastin, Herceptin, or Rituxan.
  3. Identify affected products by checking if the medication is currently within its expiration date, as all lots within the expiry period are included in this recall.
  4. Stop using any affected medications immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments and for further instructions on returning the product.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Infusion Options, Inc. directly at 718-283-7233 for additional information.
  6. For further questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare guidance and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Model:
D-1744-2019
Date Ranges: All lots within expiry
Product: Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB
Model:
D-1745-2019
Date Ranges: All lots within expiry
Product: Adcetris 96 MG/100 ML NS IVPB
Model:
D-1746-2019
Date Ranges: All lots within expiry
Product: ADO-TRASTUZUMAB (Various dosages: 150mg to 301mg) in 250 ml NS IV
Model:
D-1747-2019
Date Ranges: All lots within expiry
Product: ALIMTA 785 mg or 1000 mg in 100 ml 0.9% NACL IVPB
Model:
D-1748-2019
Date Ranges: All lots within expiry
Product: ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL
Model:
D-1749-2019
Date Ranges: All lots within expiry
Product: AVASTIN (Various dosages and concentrations) IVPB and Syringes
Model:
D-1750-2019
Date Ranges: All lots within expiry
Product: AZACITIDINE (75 MG to 135 MG) SUB-Q SYRINGE
Model:
D-1751-2019
Date Ranges: All lots within expiry
Product: BEVACIZUMAB (Various dosages: 330 MG to 1113 MG) NS IVPB
Model:
D-1752-2019
Date Ranges: All lots within expiry
Product: BLEOMYCIN 18 UNITS / 100 ML NS IVPB
Model:
D-1753-2019
Date Ranges: All lots within expiry
Product: BORTEZOMIB (Various dosages: 1.45 mg to 2.88 mg) SQ SYRINGE
Model:
D-1754-2019
Date Ranges: All lots within expiry
Product: CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB
Model:
D-1755-2019
Date Ranges: All lots within expiry
Product: CARBOPLATIN (Various dosages: 140 MG to 895 MG) IVPB
Model:
D-1756-2019
Date Ranges: All lots within expiry
Product: CARFILZOMIB (45 MG to 75 MG) in 50 ML D5W IVPB
Model:
D-1757-2019
Date Ranges: All lots within expiry
Product: CETUXIMAB 335 MG / 167.5 ML IVPB
Model:
D-1758-2019
Date Ranges: All lots within expiry
Product: Cisplatin (Various dosages and combinations with Mannitol/Magnesium) IVPB
Model:
D-1759-2019
D-1760-2019
Date Ranges: All lots within expiry
Product: Cyclophosphamide (500 MG to 1400 MG) NS IVPB
Model:
D-1761-2019
Date Ranges: All lots within expiry
Product: Cytarabine (IVPB and Syringes)
Model:
D-1762-2019
Date Ranges: All lots within expiry
Product: DACARBAZINE 675 MG or 680 MG in 250 ml NS
Model:
D-1763-2019
Date Ranges: All lots within expiry
Product: DARATUMUMAB (668 MG or 904 MG) NS IVPB
Model:
D-1764-2019
Date Ranges: All lots within expiry
Product: DARZALEX 1008 MG / 500 ML NS IVPB
Model:
D-1765-2019
Date Ranges: All lots within expiry
Product: DECITABINE 40 MG / 100 ml NS IVPB
Model:
D-1766-2019
Date Ranges: All lots within expiry
Product: DEXAMETHASONE (5 MG or 10 MG) NS IVPB
Model:
D-1767-2019
Date Ranges: All lots within expiry
Product: DIPHENHYDRAMINE 25 MG/50 ML NS
Model:
D-1768-2019
Date Ranges: All lots within expiry
Product: DOCETAXEL (30 MG to 155 MG) IVPB
Model:
D-1769-2019
Date Ranges: All lots within expiry
Product: Doxorubicin (Various dosages and combinations) IVP Syringes/IV
Model:
D-1770-2019
Date Ranges: All lots within expiry
Product: Doxorubicin Liposomal (66 MG or 71 MG) in 250 ML D5W IVPB
Model:
D-1771-2019
Date Ranges: All lots within expiry
Product: Durvalumab 650 mg or 651 mg in 250 ml NS IVPB
Model:
D-1772-2019
Date Ranges: All lots within expiry
Product: ENTYVIO 300 MG / 250 ML 0.9% NACL
Model:
D-1773-2019
Date Ranges: All lots within expiry
Product: ERBITUX (440 MG to 850 MG) IVPB
Model:
D-1774-2019
Date Ranges: All lots within expiry
Product: ERIBULIN (1.12 MG to 1.89 MG) in 100 ML NS IVPB
Model:
D-1775-2019
Date Ranges: All lots within expiry
Product: Etoposide (90 MG to 290 MG) NS/NACL IVPB
Model:
D-1776-2019
Date Ranges: All lots within expiry
Product: Fluorouracil (Various dosages and configurations) Syringe/Pump/IVPB
Model:
D-1777-2019
D-1779-2019
Date Ranges: All lots within expiry
Product: FOSAPREPITANT 150 mg/150 ml NS IVPB
Model:
D-1778-2019
Date Ranges: All lot within expiry
Product: GAZYVA (100 MG or 900 MG) in 250 ML NS IVPB
Model:
D-1780-2019
Date Ranges: All lots within expiry
Product: Gemcitabine (460 MG to 2050 MG) NS/NACL IVPB
Model:
D-1781-2019
Date Ranges: All lots within expiry
Product: GRANISETRON 1000 MCG / 50 ML NS
Model:
D-1782-2019
Date Ranges: All lots within expiry
Product: HERCEPTIN (162 MG to 650 MG) NS/NACL IVPB
Model:
D-1783-2019
Date Ranges: All lots within expiry
Product: IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG
Model:
D-1784-2019
Date Ranges: All lots within expiry
Product: InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB
Model:
D-1785-2019
Date Ranges: All lots within expiry
Product: INJECTAFER (210 MG or 720 MG) in 100 ml NS IVPB
Model:
D-1786-2019
Date Ranges: All lots within expiry
Product: IRINOTECAN (75 MG to 317 MG) D5W/NS IVPB
Model:
D-1787-2019
Date Ranges: All lots within expiry
Product: IRON SUCROSE 200 mg / 100 ML NS IVPB
Model:
D-1788-2019
Date Ranges: All lots within expiry
Product: LEUCOVORIN (300 MG to 840 MG) NS/D5W IVPB
Model:
D-1789-2019
Date Ranges: All lots within expiry
Product: METHOTREXATE (Various dosages) Syringe/IVP/IVPB
Model:
D-1790-2019
Date Ranges: All lots within expiry
Product: METHYLPREDNISOLONE 10 MG / 0.16 ML IVP
Model:
D-1791-2019
Date Ranges: All lots within expiry
Product: MITOMYCIN 10 MG / 20 ML IVP SYRINGE
Model:
D-1792-2019
Date Ranges: All lots within expiry
Product: NIVOLUMAB (165 mg to 480 MG) NS IVPB
Model:
D-1793-2019
Date Ranges: All lots within expiry
Product: ONDANSETRON 8 MG / 50 ml NS IVPB
Model:
D-1794-2019
Date Ranges: All lots within expiry
Product: OPDIVO (200 mg or 480 mg) in 100 ML NS IVPB
Model:
D-1795-2019
Date Ranges: All lots within expiry
Product: ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB
Model:
D-1796-2019
Date Ranges: All lots within expiry
Product: OXALIPLATIN (40 MG to 170 MG) D5W IVPB
Model:
D-1797-2019
Date Ranges: All lots within expiry
Product: PACLITAXEL (80 MG to 385 MG) NS/D5W IVPB
Model:
D-1798-2019
Date Ranges: All lots within expiry
Product: PACLITAXEL ALBUMIN (145 MG to 185 mg) NS IVPB
Model:
D-1799-2019
Date Ranges: All lots within expiry
Product: PACLITAXEL PROTEIN (175 MG to 355 MG) NS IVPB
Model:
D-1800-2019
Date Ranges: All lots within expiry
Product: PEMBROLIZUMAB 200 MG / 100 ML NS IVPB
Model:
D-1801-2019
Date Ranges: All lots within expiry
Product: PANITUMUMAB 400 MG / 100 ml NS IVPB
Model:
D-1802-2019
Date Ranges: All lots within expiry
Product: PEMETREXED (490 MG to 1000 mg) NS/NACL IVPB
Model:
D-1803-2019
Date Ranges: All lots within expiry
Product: PERJETA 420 MG/250 ml 0.9% NACL IVPB
Model:
D-1804-2019
Date Ranges: All lots within expiry
Product: PERTUZUMAB 840 MG/250 ml 0.9% NACL IVPB
Model:
D-1805-2019
Date Ranges: All lots within expiry
Product: PRESERVATIVE FREE 0.9% NACL 5 ML SYR
Model:
D-1806-2019
Date Ranges: All lots within expiry
Product: RAMUCIRUMAB (457 MG or 1182 MG) NS IVPB
Model:
D-1807-2019
Date Ranges: All lots within expiry
Product: REMICADE (270 MG to 1200 MG) NACL/NS IVPB
Model:
D-1808-2019
Date Ranges: All lots within expiry
Product: RITUXAN (500 MG to 1000 MG) NACL/NS IVPB
Model:
D-1809-2019
Date Ranges: All lots within expiry
Product: RITUXIMAB (575 MG to 1000 MG) NACL/NS IVPB
Model:
D-1810-2019
Date Ranges: All lots within expiry
Product: RomiPLOStim 700 MCG/ 1.4 ML SQ SYR
Model:
D-1811-2019
Date Ranges: All lots within expiry
Product: Sodium Chloride 0.9% 1 LITER with KCl, Mannitol, Magnesium Sulfate
Model:
D-1812-2019
Date Ranges: All lots within expiry
Product: SOLIRIS (900 MG or 1200 MG) NACL 0.9% IVPB
Model:
D-1813-2019
Date Ranges: All lots within expiry
Product: TOPOTECAN 1.24 MG / 100 ML NS IVPB
Model:
D-1814-2019
Date Ranges: All lots within expiry
Product: TRASTUZUMAB (114 MG to 781 MG) NS IVPB
Model:
D-1815-2019
Date Ranges: All lots within expiry
Product: VELCADE (1.7 mg to 4 mg) SQ SYRINGE
Model:
D-1816-2019
Date Ranges: All lots within expiry
Product: VINBLASTINE 10.8 MG or 10.9 MG in 100 ML D5W IVPB
Model:
D-1817-2019
Date Ranges: All lots within expiry
Product: VINCRISTINE (1 MG to 2 MG) IVPB/IVP
Model:
D-1818-2019
Date Ranges: All lots within expiry
Product: FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB
Model:
D-1819-2019
Date Ranges: All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83136
Status: Resolved
Manufacturer: Infusion Options, Inc.
Sold By: Infusion Options, Inc.
Manufactured In: United States
Units Affected: 820 60 units/bag
Distributed To: New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.