FDA-Drug2018-03-07Class II
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.
ALLERGAN
Hazard
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Sold states
Product was distributed nationwide in the USA.
Affected count
163,694 cartons
Manufactured in
1 Giralda Farms, N/A, Madison, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2018Don't want to check this manually?
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