The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1783-2019·Announced 2019-08-21

Infusion Options Recalls HERCEPTIN Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling HERCEPTIN infusion bags in New York due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a risk of harm (infection) without reported illnesses or injuries in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Infusion Options, Inc. is recalling multiple HERCEPTIN infusion bags (IVPB) in various concentrations (162 mg to 650 mg per 250 ml) in New York. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products are 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, and HERCEPTIN 472 MG / 250 ML NS IVPB. The recall covers all lots within expiry. The distribution was limited to New York.

Patients who have received these infusions should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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…
Manufacturer
Infusion Options, Inc.
Category
Drug — Biologic / Infusion
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 76 products in this recall →

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