The Recall Desk

FDA (Drugs) recall action 68348

Bausch & Lomb, Inc. recalled 2 products on 2014-07-02

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-07-02
Critical
0
Units
35,253

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2014-07-02

    Bausch & Lomb Recalls Sodium Chloride Ophthalmic Ointment Due to Crystallization

    Bausch & Lomb is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, due to crystal precipitate formation causing a gritty sensation in the eye.

    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.
    Category
    Distribution
    1 state