CLASS II Drug recall · Reported 5 Dec 2018 · FDA Enforcement Report
INFed (Iron Dextran Injection USP) 100 mg elemental iron/ (50 mg/mL) recalled
Allergan is recalling INFed (Iron Dextran Injection USP) 100 mg elemental iron/ (50 mg/mL), distributed nationwide in the US. The recall was initiated on 8 Nov 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0282-2019
- FDA event ID
- 81535
- Recalling firm
- Allergan, Madison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2018
- FDA classified
- 23 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Nov 2018 | Recall initiated by company | |
| 23 Nov 2018 | Classified by FDA | +15 days |
| 5 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specification: out of specification for iron content.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Failed Stability Specification: out of specification for iron content.
Which lots are affected?
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
Where was it sold?
Product was distributed throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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