FDA Recall D-0551-2018
Kareway Products Inc · Compton, CA
Class I — life-threatening Terminated 636 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0551-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
- Recall initiated
- 2017-11-09
- Classified by FDA Center
- 2018-02-28
- FDA published
- 2018-03-07
- Terminated
- 2019-08-07
- Recalling firm
- Kareway Products Inc
- Firm location
- Compton, CA