The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1781-2019·Announced 2019-08-21

Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Gemcitabine infusion bags 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. The hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death from infection, fitting the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Gemcitabine intravenous infusion bags (IVPB) in various concentrations. The affected products are distributed in New York and include specific milligram amounts per 250 mL of normal saline. The recall covers all lots within their expiration dates.

The reason for the recall is a lack of assurance of sterility. This means the manufacturer cannot guarantee that the products are free from microbial contamination. The products are prescription-only medications intended for intravenous use.

Healthcare providers and patients who have received or are scheduled to receive these specific Gemcitabine infusions should contact their healthcare provider or Infusion Options, Inc. for further instructions. The company is located in Brooklyn, NY, and can be reached at 718-283-7233.

The recalled product

Product
Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine…
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