D-1410-2014 Class II Terminated
FDA drug recall D-1410-2014 was initiated by Bausch & Lomb, Inc. on Apr 10, 2014 and is designated Class II. 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. The recall status is terminated (terminated Apr 14, 2017). Affected quantity: a) 4,165 tubes; b) and c) 844,879 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 2, 2014
- Initiation Date
- Apr 10, 2014
- Termination Date
- Apr 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 4,165 tubes; b) and c) 844,879 tubes
Product Description
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.
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 Pattern
Nationwide, Puerto Rico, Canada, and Hong Kong.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1410-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026