CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Doxorubicin 110 MG / IVP Syringe recalled by Infusion Options
Infusion Options is recalling Doxorubicin 110 MG / IVP Syringe, distributed in New York. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1770-2019
- FDA event ID
- 83136
- Recalling firm
- Infusion Options, Brooklyn, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2019
- FDA classified
- 15 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jun 2019 | Recall initiated by company | |
| 15 Aug 2019 | Classified by FDA | +64 days |
| 21 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
NY only
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots within expiry
Where was it sold?
NY only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
75 other products · FDA event 83136This product is part of a recall event; the main page for the event is Injectafer 720 MG in NS Ivpb recalled by Infusion Options.
More recalls from Infusion Options
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pembrolizumab 200 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Calcium Gluconate 1 Gm / Nacl 0.9% Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Oxaliplatin 145 MG / D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Cetuximab 335 MG / Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Eribulin 1.12 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
Other Doxorubicin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Doxil (doxorubicin hydrochloride liposome injection) 50 mg recalledDoxil | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | DOXOrubicin Hydrochloride Injection, USP, 10 mg recalledDoxorubicin Hydrochloride | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS II | DOXOrubicin Hydrochloride Liposome Injection, 20 mg recalledDoxorubicin Hydrochloride | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS III | DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled | Mylan Institutional | Packaging Defects | Nationwide |