CLASS I Drug recall · Reported 7 Mar 2018 · FDA Enforcement Report
Gericare Eyewash, sterile eye irrigating solution recalled
Kareway Products is recalling Gericare Eyewash, sterile eye irrigating solution, distributed nationwide in the US. The recall was initiated on 9 Nov 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0551-2018
- FDA event ID
- 78541
- Recalling firm
- Kareway Products, Compton, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Nov 2017
- FDA classified
- 28 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 9 Nov 2017 | Recall initiated by company | |
| 28 Feb 2018 | Classified by FDA | +111 days |
| 7 Mar 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Questions about this recall
Why was it recalled?
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Which lots are affected?
Lot #: 86041601, Exp 09/19
Where was it sold?
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.