D-0496-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- September 2, 2016
- Termination Date
- June 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,080 bottles
Product Description
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Reason for Recall
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Distribution Pattern
Nationwide, Puerto Rico and Guyana
Code Information
Lot # G15905, G15907, Exp 10/2018