FDA recall D-0551-2018

Product

GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04

Reason for recall

Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans

Distribution

Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.

Key facts

Status

Terminated

Initiation date

2017-11-09

Report date

2018-03-07

Termination date

2019-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Compton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2018