Recalls / Class II
Class IID-1410-2014
Product
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.
- Brand name
- Muro 128
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Ophthalmic
- NDC
- 24208-385
- FDA application
- M018
- Affected lot / code info
- 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
Why it was recalled
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Manufacturer
- Bausch & Lomb Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- a) 4,165 tubes; b) and c) 844,879 tubes
- Distribution pattern
- Nationwide, Puerto Rico, Canada, and Hong Kong.
Timeline
- Recall initiated
- 2014-04-10
- FDA classified
- 2014-06-25
- Posted by FDA
- 2014-07-02
- Terminated
- 2017-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1410-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.