D-0499-2017 Class II 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
- 190,710 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
Lack of assurance of sterility
Distribution Pattern
Nationwide, Puerto Rico and Guyana
Code Information
Lot # G15906, Exp 10/2018; G15910, G15911, G15912, Exp 11/2018; G16901, G16902, G16903, Exp 01/2019; G16905, G16906, G16907, Exp 02/2019; G16910, G16911, Exp 03/2019