CLASS II Drug recall · Reported 7 Mar 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 13 Dec 2017 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-0545-2018
- FDA event ID
- 78755
- Recalling firm
- Allergan, Madison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Dec 2017
- FDA classified
- 23 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Dec 2017 | Recall initiated by company | |
| 23 Feb 2018 | Classified by FDA | +72 days |
| 7 Mar 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 Specifications: Product stability testing results did not meet specifications 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 a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Where it was distributed
Product was distributed nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Which lots are affected?
Lot# 15W05A, Exp.FEB-2018; 16W02A, Exp. DEC 2018; 16W05A, Exp. JAN-2019; 16W13A, Exp. APR-2019; 16W15A, 16W16A, 16W17A, Exp. MAY 2019; 16W18A, Exp. JUN 2019; 16W20A, 16W22A, Exp. SEP 2019; 17W01A, 17W02A, Exp. DEC-2019; 17W04A, 17W05A, Exp. JAN 2020; 17W09A, Exp. MAR-2020; 17W11A, 17W13A, Exp. MAY 2020; 17W14A, 17W15A, Exp. JUN 2020
Where was it sold?
Product was distributed nationwide in the USA.
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.
More recalls from Allergan
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Refresh Contacts¿ Contact Lens Comfort Drops Sterile recalled | Allergan | Other | MO |
| Drug | CLASS II | Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile recalledRefresh Relieva Preservative Free | Allergan | Other | Nationwide |
| Drug | CLASS III | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) recalled | Allergan | Potency & Assay | Nationwide |
| Drug | CLASS III | Skin Medica Acne System, Contains: Purifying Foaming Wash recalled | Allergan | Potency & Assay | Nationwide |
| Device | CLASS II | XEN Gel Stent recalled by Allergan | Allergan | Sterility | Nationwide |