The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1788-2019·Announced 2019-08-21

Iron Sucrose Infusion Recalled for Lack of Sterility Assurance

Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.

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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in an IV product is categorized as Severe (Score 4), particularly given the potential for serious adverse health consequences even if the probability is remote.

Plain-English summary

Infusion Options, Inc. is recalling Iron Sucrose 200 mg / 100 ML NS IVPB, a prescription-only intravenous product. The recall was initiated because of a lack of assurance of sterility. The product is manufactured by Infusion Options, Inc., located in Brooklyn, New York.

The recall affects all lots within their expiration dates. Distribution was limited to New York only. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Infusion Options, Inc. is the recalling firm responsible for managing the recall.

The recalled product

Product
IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — IV Infusion
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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