The Recall Desk
SevereFDA (Drugs)·D-1792-2019·Announced 2019-08-21

Infusion Options Recalls Mitomycin Syringes Due to Sterility Concerns

Infusion Options, Inc. is recalling Mitomycin 10 mg/20 mL IVP syringes in New York due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, and the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection or serious injury.

Plain-English summary

Infusion Options, Inc. is recalling Mitomycin 10 mg/20 mL IVP syringes. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is a prescription-only intravenous (IVP) syringe. The recall covers all lots within their expiration dates. The distribution pattern for this recall is limited to New York.

Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm, Infusion Options, Inc., for further instructions.

The recalled product

Product
MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Antineoplastic
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 →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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