FDAFDA · Food and drugs·Recall number D-1411-2014
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.
Published July 2, 2014 · Recall initiated: April 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bausch & Lomb, Inc.
- Distributor
- Nationwide, Puerto Rico, Canada, and Hong Kong.
- Lot
- Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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