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

FDA recall notice · announced March 7, 2018 · Kareway Products

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Lot/code information: Lot #: 86041601, Exp 09/19
Quantity: 60,000 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0551-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.