HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250 ML NS IVPB; HERCEPTIN 650 MG / 250 ML NS IVPB; HERCEPTIN 472 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Recall Number: D-1783-2019

Firm: Infusion Options, Inc.

Classification: Class II

Status: Terminated

Report Date: 20190821

Initiation Date: 20190612

Termination Date: 20250321

Reason for Recall

Lack of Assurance of Sterility

Product Description

HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250 ML NS IVPB; HERCEPTIN 650 MG / 250 ML NS IVPB; HERCEPTIN 472 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233