Bortezomib Syringes Recalled for Lack of Sterility Assurance

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 SYRINGE,

Manufacturer

Infusion Options, Inc.

Category

Drug — Injectable

Hazard

• sterility

Is your product affected?

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

Distribution

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