The Recall Desk
LowFDA (Drugs)·D-162-2013·Announced 2013-02-20

Ranbaxy Recalls Lac-Hydrin Lotion Due to Crystallization Texture

Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin Lotion, 12%, due to a gritty texture caused by crystallization.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a cosmetic texture defect (crystallization) rather than a safety hazard.

Plain-English summary

Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The specific lot number is RB93911, with an expiration date of 07/14.

The recall is due to a non-characteristic gritty or sandy texture in the product, which is likely caused by crystallization. This is a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return or dispose of the medication.

The recalled product

Product
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
Manufacturer
Ranbaxy Inc.
Category
Drug — Topical Prescription
Hazard
Affected units
4,016

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 (2)

  • Lot #: RB93911
  • Exp 07/14

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 Ranbaxy 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 →

Related recalls

Same manufacturer · Ranbaxy Inc.

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Same hazard · crystallization

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