Reported Mar 7, 2018 · Terminated
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials,…
Allergan
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ALLERGAN · 1 Giralda Farms · Madison, NJ · 07940-1027
Is this the product you have?
- 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 byActavis Pharma, Inc. Parsippany, NJ 07054
- Manufactured byPatheon Italia S.p.A. Ferentino, Italy 03013
- Lot codes and dates
Lot# 15W05AExp.FEB-201816W02AExp. DEC 201816W05AExp. JAN-201916W13AExp. APR-201916W15A16W16A16W17AExp. MAY 201916W18AExp. JUN 201916W20A16W22AExp. SEP 201917W01A17W02AExp. DEC-201917W04A17W05AExp. JAN 202017W09AExp. MAR-202017W11A17W13AExp. MAY 202017W14A17W15AExp. JUN 2020
- Amount recalled
- 163,694 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
This product could cause temporary or reversible health problems — stop using it.
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