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U.S. Department of Health and Human Services

Enforcement Report - Week of July 2, 2014

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Product Detail

Product Description 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.
Recall Number D-1411-2014
Classification Class II
Code Info Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
Product Distributed Qty 35,253 tubes
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.

Event Detail

Event Id 68348
Product Type Drugs
Status Ongoing
Recalling Firm Bausch & Lomb, Inc.
City Tampa
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Puerto Rico, Canada, and Hong Kong.