FDAFDA · Food and drugs·Recall number D-0282-2019
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
Published December 5, 2018 · Recall initiated: November 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specification: out of specification for iron content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ALLERGAN
- Distributor
- Product was distributed throughout the United States.
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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