November 2018 FDA Recall Drug by Allergan
D-0282-2019 - Failed Stability Specification

This Class II drug recall was voluntarily initiated by Allergan on November 8, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specification. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0282-2019

Reason for Recall
Failed Stability Specification: out of specification for iron content.
Initiated
11-08-2018
Reported
12-05-2018
Quantity
111,132 cartons/10 vials per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81535
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ALLERGAN
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-06-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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, exp. date 06/2020; 17W22A, exp. date 08/2020