November 2017 FDA Recall Drug by Kareway Products Inc
D-0551-2018 - Non-sterility
This Class I drug recall was voluntarily initiated by Kareway Products Inc on November 9, 2017 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0551-2018
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
11-09-2017
03-07-2018
60,000 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kareway Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
08-07-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : 86041601, Exp 09/19
