FDA Drug Recalls

Recalls / Class II

Class IID-1750-2019

Product

AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG/100 ML 0.9% NACL IVPB; AVASTIN 250 MG / 100 ML 0.9% NACL IVPB; AVASTIN 693.125 MG/100 ML 0.9% NACL IVPB; AVASTIN 1020 MG/100 ML NS IVPB; AVASTIN 811.875 MG/100 ML 0.9% NACL IVPB; AVASTIN 1006.25 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

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-1750-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.