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
Reported: March 7, 2018 Initiated: November 9, 2017 #D-0551-2018
Product Description
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
Details
- Recalling Firm
- Kareway Products Inc
- Units Affected
- 60,000 bottles
- Distribution
- Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
- Location
- Compton, CA
Frequently Asked Questions
What product 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. Recalled by Kareway Products Inc. Units affected: 60,000 bottles.
Why was this product recalled? ▼
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Critical. Recall number: D-0551-2018.
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