Class II
Terminated
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.
This recall has been terminated (originally issued July 2, 2014).
- Company
- Bausch & Lomb, Inc.
- Recall Initiated
- April 10, 2014
- Posted
- July 2, 2014
- Recall Number
- D-1411-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35,253 tubes
- Firm Location
- Tampa, FL, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
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