Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonvi...
FDA Recall #D-162-2013 — Class III — December 27, 2012
Product Description
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.
Recalling Firm
Ranbaxy Inc. — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,016 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: RB93911, Exp 07/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated