FDA recall D-162-2013

Product

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.

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-162-2013