GERICARE Eyewash recalled over sterility concerns

Recall date

November 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Kareway Products Inc recalls GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care…

Recall number

D-0551-2018

FDA classification

Class I

Brand / firm

Kareway Products Inc

Sold / distributed

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

Why it was recalled

Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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