FDA Drug Recalls

Recalls / Class II

Class IID-1771-2019

Product

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

Affected lot / code info
All lots within expiry

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Infusion Options, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
5924 13th Ave, N/A, Brooklyn, New York 11219-4934

Distribution

Quantity
N/A
Distribution pattern
NY only

Timeline

Recall initiated
2019-06-12
FDA classified
2019-08-15
Posted by FDA
2019-08-21
Terminated
2025-03-21
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1771-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls