The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1410-2014·Announced 2014-07-02

Bausch & Lomb Recalls Muro 128 Ophthalmic Ointment Due to Crystallization

Bausch & Lomb is recalling Muro 128 ophthalmic ointment because crystals form in the product, causing a gritty feeling in the eye.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves physical irritation (gritty feeling) rather than a high-risk pathogen or structural defect causing serious injury.

Plain-English summary

Bausch & Lomb, Inc. is recalling Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%. The recall affects multiple package sizes, including 1 g tubes, 1/8 oz. tubes, and 1/4 oz. twin packs, distributed nationwide, in Puerto Rico, Canada, and Hong Kong.

The recall is being conducted because of crystal precipitate formation in the ointment. This defect has led to an increase in complaints from users experiencing a gritty, sand-like feeling in the eye.

Consumers should stop using the recalled product and contact Bausch & Lomb for instructions on how to return the product or obtain a refund.

The recalled product

Product
MURO 128 (SODIUM CHLORIDE)
Brand
MURO 128
Manufacturer
Bausch & Lomb, Inc.
Category
Drug — Ophthalmic Ointment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (3)

  • 0324208385562
  • 324208385012
  • 324208385555

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Bausch & Lomb, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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