CLASS II Drug recall · Reported 2 Jul 2014 · FDA Enforcement Report

Muro 128 (sodium chloride) hypertonicity ophthalmic ointment recalled

Bausch & Lomb is recalling Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, distributed nationwide in the US. The recall was initiated on 10 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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

NDC24208-385

UPC0324208385562, 324208385012, 324208385555

Quantity recalleda) 4,165 tubes; b) and c) 844,879 tubes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1410-2014
FDA event ID: 68348
Recalling firm: Bausch & Lomb, Tampa, FL
Brand: Muro 128
Manufacturer: Bausch & Lomb Incorporated
Classification: Class II
Status: Terminated
Recall initiated: 10 Apr 2014
FDA classified: 25 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Eye Drops

Timeline

10 Apr 2014	Recall initiated by company
25 Jun 2014	Classified by FDA	+76 days
2 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Nationwide, Puerto Rico, Canada, and Hong Kong.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Which lots are affected?

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

Where was it sold?

Nationwide, Puerto Rico, Canada, and Hong Kong.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 68348

This product is part of a recall event; the main page for the event is Sodium Chloride Hypertonicity Ophthalmic Ointment, 5% tube recalled.

Reported	Class	Recall	Company	Reason	Where
2 Jul 2014	CLASS II	Sodium Chloride Hypertonicity Ophthalmic Ointment, 5% tube recalled	Bausch & Lomb	Other	Nationwide

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