The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1754-2019·Announced 2019-08-21

Bortezomib Syringes Recalled for Lack of Sterility Assurance

Infusion Options, Inc. is recalling Bortezomib 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. According to the rubric, FDA Class II recalls involving potential hospitalization or significant injury risks (such as sterility issues in injectable drugs) are rated as Severe.

Plain-English summary

Infusion Options, Inc. is recalling Bortezomib subcutaneous syringes in various concentrations, including 2.5 mg/1 mL, 2.88 mg/1.15 mL, 2.31 mg/0.92 mL, 2.7 mg/1.08 mL, 1.45 mg/0.58 mL, 2.25 mg/0.9 mL, and 1.98 mg/0.79 mL. The recall is limited to products distributed in New York.

The reason for the recall is a lack of assurance of sterility. The source text does not specify which lots are affected, stating only that all lots within expiry are involved. No specific dates or quantities are provided in the notice.

Patients and healthcare providers who have received these products should contact Infusion Options, Inc. or their healthcare provider for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB 2.7 mg / 1.08 ML SQ SYRINGE; BORTEZOMIB 1.45 mg / 0.58 ml SQ SYRINGE; BORTEZOMIB 2.25 mg (0.9 ML) SQ SYRINGE; BORTEZOMIB 1.98 mg / 0.79 ml SQ…
Manufacturer
Infusion Options, Inc.
Category
Drug — Injectable
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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