D-0551-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 7, 2018
- Initiation Date
- November 9, 2017
- Termination Date
- August 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,000 bottles
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
Distribution Pattern
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Code Information
Lot #: 86041601, Exp 09/19