FDA recall D-163-2013

Ranbaxy Inc. · Class III · drug

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.

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-12-27
Report date: 2013-02-20
Termination date: 2014-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-163-2013