Class II · Moderate risk
Doxil (doxorubicin hydrochloride liposome injection)
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Doxorubicin 110 MG / 55 ML IVP SYRINGE
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Drug: Doxorubicin
- Recalling firm
- Infusion Options, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1770-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Doxorubicin recalls
See all
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class II · Moderate risk
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
DOXOrubicin Hydrochloride Liposome Injection
Lack Of Assurance Of Sterility
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Other recalls by Infusion Options, Inc.
All 2019 recalls
Class II · Moderate risk
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Vincristine 1 Mg /50 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Vinblastine 10.9 Mg / 100 Ml D5w Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
VELCADE 2.1 mg / 0.84 ml SQ SYRINGE
Lack of Assurance of Sterility
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