CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Docetaxel 60 MG / D5w Ivpb recalled by Infusion Options
Infusion Options is recalling Docetaxel 60 MG / D5w Ivpb, 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-1769-2019
- 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
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
Where it was distributed
NY only
Questions about this recall
Is Docetaxel 60 MG / D5w Ivpb recalled?
Yes. Infusion Options recalled Docetaxel 60 MG / D5w Ivpb on 12 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1769-2019.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 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 12 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |