D-0545-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 7, 2018
- Initiation Date
- December 13, 2017
- Termination Date
- April 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163,694 cartons
Product Description
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 for Recall
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Distribution Pattern
Product was distributed nationwide in the USA.
Code Information
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