PlainRecalls
FDA Drug Moderate Class II Terminated

ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Reported: August 21, 2019 Initiated: June 12, 2019 #D-1774-2019

Product Description

ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Infusion Options, Inc.
Units Affected
N/A
Distribution
NY only
Location
Brooklyn, NY

Frequently Asked Questions

What product was recalled?
ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233. Recalled by Infusion Options, Inc.. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1774-2019.