Reported Dec 5, 2018 · Terminated
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose…
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 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
- Lot codes and dates
- Lot Numbers
16W06A16W07A16W08Aexp. date 02/201916W09A16W10Aexp. date 03/201916W11A16W14Aexp. date 04/201916W21Aexp. date 09/201916W23Aexp. date 11/201917W10Aexp. date 04/202017W12Aexp. date 05/202017W16A17W18Aexp. date 06/202017W22Aexp. date 08/2020
- Lot Numbers
- Amount recalled
- 111,132 cartons/10 vials per carton
Why it was recalled
Failed Stability Specification: out of specification for iron content.
This product could cause temporary or reversible health problems — stop using it.
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