Drug recall
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by…
FDA recall event 78541 · Class I · Kareway Products Inc
Key facts
| Event ID | 78541 |
|---|---|
| Recall numbers | D-0551-2018 |
| Recalling firm | Kareway Products Inc |
| Product type | Drugs |
| 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 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans |
| Initiation date | Nov 9, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Aug 7, 2019 |
| City | Compton |
| State | CA |
| Country | United States |
| FEI number | 3009390058 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: