Food, drugs, devices › Bausch & Lomb, Inc.
Drug recall: Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sampl
Bausch & Lomb, Inc. (Tampa, FL) initiated this drug recall on 10 Apr 2014; FDA lists 2 product records under event 68348, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 58% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 14 Apr 2017. Initiation: voluntary: firm initiated. Bausch & Lomb, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bausch & Lomb, Inc., Tampa, FL.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1410-2014 | 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… | a) 4,165 tubes; b) and c) 844,879 tubes | Class II | Terminated | 2 Jul 2014 |
| D-1411-2014 | 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. | 35,253 tubes | Class II | Terminated | 2 Jul 2014 |
Context
Other enforcement events for Bausch & Lomb, Inc.
All 9 events for Bausch & Lomb, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide, Puerto Rico, Canada, and Hong Kong."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.