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U.S. Department of Health and Human Services

Enforcement Report - Week of July 2, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. 35,253 tubes D-1411-2014
Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637. Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. a) 4,165 tubes; b) and c) 844,879 tubes D-1410-2014
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