The Recall Desk
LowFDA (Drugs)·D-163-2013·Announced 2013-02-20

Ranbaxy Recalls Lac-Hydrin Cream Due to Crystallization

Ranbaxy Inc. is recalling specific lots of Lac-Hydrin (ammonium lactate) Cream, 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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a cosmetic texture defect (crystallization) with no reported injuries or illnesses.

Plain-English summary

Ranbaxy Inc. is recalling 6,535 tubes and bottles of Lac-Hydrin (ammonium lactate) Cream, 12%. The affected products are packaged in 280 g (2 x 140 g tubes) and 385 g bottles. The recall covers lots RB91881 (Exp 07/14) and RB91891 (Exp 07/13).

The recall is due to a non-characteristic gritty or sandy texture in the product, which is likely caused by crystallization. The FDA has classified this as a Class III recall.

The affected products were distributed nationwide and in Puerto Rico. Consumers should check their lot numbers and expiration dates against the recalled items listed above.

The recalled product

Product
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
Manufacturer
Ranbaxy Inc.
Category
Drug — Topical Cream
Hazard
Affected units
6,535

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 (4)

  • Lot #: RB91881
  • Exp 07/14
  • RB91891
  • Exp 07/13

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 →

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