# FDA recall D-162-2013

> **Ranbaxy Inc.** · Class III · drug recall initiated 2012-12-27.

## Product

Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.

## Reason for recall

Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-162-2013
- **Recalling firm:** Ranbaxy Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-27
- **Report date:** 2013-02-20
- **Termination date:** 2014-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-162-2013

## Citation

> AI Analytics. FDA recall D-162-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-162-2013. Source: US FDA. Licensed CC0.

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