# FDA recall D-1411-2014

> **Bausch & Lomb, Inc.** · Class II · drug recall initiated 2014-04-10.

## 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.

## 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.

## Key facts

- **Recall number:** D-1411-2014
- **Recalling firm:** Bausch & Lomb, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-10
- **Report date:** 2014-07-02
- **Termination date:** 2017-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2014

## Citation

> AI Analytics. FDA recall D-1411-2014. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-1411-2014. Source: US FDA. Licensed CC0.

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