Multi-event December 2012 FDA Recall Drug by Ranbaxy Inc.

This Multi-event Class III drug recall was voluntarily initiated by Ranbaxy Inc. on December 27, 2012 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-162-2013 TERMINATED D-163-2013 TERMINATED

Recall Number: D-162-2013

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.
Initiated
12-27-2012
Reported
02-20-2013
Quantity
4,016 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64286
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ranbaxy Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-09-2014
Product Description About Product Description
Full technical description of the product.
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.

Batch or Lot Expiration Information

Lot# : RB93911, Exp 07/14

Recall Number: D-163-2013

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.
Initiated
12-27-2012
Reported
02-20-2013
Quantity
6,535 tubes and bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64286
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ranbaxy Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-09-2014
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : RB91881, Exp 07/14; RB91891, Exp 07/13