FDA-Drug2018-03-07Class I

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

Kareway Products Inc
Hazard

Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans

Sold states
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Affected count
60,000 bottles
Manufactured in
2550 S Dominguez Hills Dr, N/A, Compton, CA, United States
Products
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

Official notice

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

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