FDA recall D-1411-2014

Product

Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.

Reason for recall

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Distribution

Nationwide, Puerto Rico, Canada, and Hong Kong.

Key facts

Status

Terminated

Initiation date

2014-04-10

Report date

2014-07-02

Termination date

2017-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2014