The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1818-2019·Announced 2019-08-21

Infusion Options Recalls Vincristine Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling specific vincristine infusion products 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 and involves a lack of assurance of sterility in a parenteral drug, which poses a risk of serious injury or death if contaminated, meeting the criteria for a Severe rating.

Plain-English summary

Infusion Options, Inc. is recalling four specific vincristine infusion products: Vincristine 1 mg/50 mL NS IVPB, Vincristine 1.2 mg/50 mL NaCl 0.9% IVPB, Vincristine 1 mg/1 mL IVP Syringe, and Vincristine 2 mg/100 mL D5W IVPB. These prescription-only products were distributed in New York only. The recall is being conducted because of a lack of assurance of sterility.

The affected products include all lots within their expiration dates. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific lot numbers or dates are provided in the source text.

Healthcare providers and patients who have received these products should contact Infusion Options, Inc. at 718-283-7233 for further information. Consumers should not use the recalled products and should return them to the pharmacy or healthcare provider.

The recalled product

Product
VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, 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.

See all →

Same hazard · sterility

See all →

Similar recalls