The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1816-2019·Announced 2019-08-21

Infusion Options Recalls Velcade Syringes Due to Sterility Concerns

Infusion Options, Inc. is recalling various Velcade subcutaneous syringes 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls.

Plain-English summary

Infusion Options, Inc. is recalling multiple strengths of Velcade subcutaneous syringes. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products include Velcade syringes in various milligram and milliliter concentrations, including 2.1 mg/0.84 ml, 2.5 mg/1 ml, 2.2 mg/0.88 ml, 2.6 mg/1.04 ml, 4 mg/1.6 ml, 2.75 mg/1.1 ml, 1.7 mg/0.68 ml, 3.5 mg/1.4 ml, 2.33 mg/0.93 ml, 2.4 mg/0.96 ml, and 2.63 mg/1.052 ml. The recall covers all lots within their expiration dates.

The distribution of these products was limited to New York. Consumers and healthcare providers should stop using the affected syringes and contact Infusion Options, Inc. for further instructions or a replacement.

The recalled product

Product
VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg…
Manufacturer
Infusion Options, Inc.
Category
Drug — Biologic / Oncology
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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