FDA Drug recall D-0545-2018
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)…
- FDA Drug
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of 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)… by Allergan, citing failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0545-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-13 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Allergan |
| Distribution | US |
Product
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.
Reason
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Identifiers
| code_info | Lot# 15W05A, Exp.FEB-2018; 16W02A, Exp. DEC 2018; 16W05A, Exp. JAN-2019; 16W13A, Exp. APR-2019; 16W15A, 16W16A, 16W17A,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2018%22
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