D-0282-2019 Class II Terminated
FDA drug recall D-0282-2019 was initiated by ALLERGAN on Nov 8, 2018 and is designated Class II. Reason for recall: Failed Stability Specification: out of specification for iron content. The recall status is terminated (terminated Apr 6, 2020). Affected quantity: 111,132 cartons/10 vials per carton.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 5, 2018
- Initiation Date
- Nov 8, 2018
- Termination Date
- Apr 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111,132 cartons/10 vials per carton
Product Description
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
Reason for Recall
Failed Stability Specification: out of specification for iron content.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0282-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026