FDA-Drug2018-06-20Class II

Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167

RIJ Pharmaceutical LLC
Hazard

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Sold states
Nationwide in the USA
Affected count
8124 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2018

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