The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1767-2019·Announced 2019-08-21

Infusion Options Recalls Dexamethasone Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling specific dexamethasone 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination scenarios.

Plain-English summary

Infusion Options, Inc. is recalling Dexamethasone 10 mg / 50 mL NS IVPB, Dexamethasone 5 mg / 50 mL NS, and Dexamethasone 5 mg / 50 mL NS IVPB. The recall is being conducted because of a lack of assurance of sterility for these products.

The affected products are prescription-only (Rx Only) and were distributed in New York. The recall covers all lots within their expiration dates. The manufacturer is located at 5924 13th Ave, Brooklyn, NY 11219-4934.

Consumers and healthcare providers should stop using these products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.

The recalled product

Product
DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 MG / 50 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Injectable Sterile Solution
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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