Sodium Chloride Hypertonicity Ophthalmic Ointment recall
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.
Why was Sodium Chloride Hypertonicity Ophthalmic Ointment recalled?
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
- 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.
- Recalling firm
- Bausch & Lomb, Inc.
- Quantity
- 35,253 tubes
- Distribution
- Nationwide, Puerto Rico, Canada, and Hong Kong.
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)