The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1411-2014·Announced 2014-07-02

Bausch & Lomb Recalls Sodium Chloride Ophthalmic Ointment Due to Crystallization

Bausch & Lomb is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, due to crystal precipitate formation causing a gritty sensation 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 sensation) without reports of serious injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Bausch & Lomb, Inc. is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton. The product is distributed by Major Pharmaceuticals and is identified by NDC 0904-5315-38 and UPC 3 09045 31538 5.

The recall was initiated due to crystal precipitate formation and an increase in complaints associated with a gritty, sand-like feeling in the eye. The affected lots are 159101 (Exp 02/15), 169271 (Exp 09/15), and 170481 (Exp 10/15).

The product was distributed nationwide, as well as in Puerto Rico, Canada, and Hong Kong. Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
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.
Manufacturer
Bausch & Lomb, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
35,253

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 (6)

  • Lot #'s: 159101
  • Exp 02/15
  • 169271
  • Exp 09/15
  • and 170481
  • Exp 10/15

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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