Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-2...
FDA Recall #D-163-2013 — Class III — December 27, 2012
Product Description
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.
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
6,535 tubes and bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated