FDA-Drug2021-06-02Class II
Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
357 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2021Don't want to check this manually?
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