The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0282-2019·Announced 2018-12-05

Allergan Recalls INFed Iron Dextran Injection for Stability Failure

Allergan is recalling INFed (Iron Dextran Injection) vials because they failed stability specifications for iron content. The product was distributed throughout the United States.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a stability specification failure regarding iron content, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/specification errors without reported harm.

Plain-English summary

Allergan is recalling INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), packaged in 2 mL sterile single-dose vials. The recall involves 111,132 cartons, with 10 vials per carton. The product was distributed throughout the United States.

The recall was initiated because the product failed stability specifications, specifically being out of specification for iron content. The affected lot numbers include 16W06A through 17W22A, with expiration dates ranging from February 2019 to August 2020.

Healthcare providers and patients should discontinue use of the affected lots and contact Allergan for further instructions. Consumers should check their medication vials against the listed lot numbers and expiration dates to determine if they are affected.

The recalled product

Product
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Manufacturer
ALLERGAN
Category
Drug — Injection
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 (20)

  • Lot Numbers: 16W06A
  • 16W07A
  • 16W08A
  • exp. date 02/2019
  • 16W09A
  • 16W10A
  • exp. date 03/2019
  • 16W11A
  • 16W14A
  • exp. date 04/2019
  • 16W21A
  • exp. date 09/2019
  • 16W23A
  • exp. date 11/2019
  • 17W10A
  • exp. date 04/2020
  • 17W12A
  • exp. date 05/2020
  • 17W16A
  • 17W18A

Distribution

Distribution scope not specified by the agency.

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