FDA recall D-0853-2018

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-06-20

Termination date

2023-04-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Middletown, NY, United States

Primary source

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