FDA-Drug2013-02-20Class III
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.
Ranbaxy Inc.
Hazard
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Sold states
Nationwide and Puerto Rico
Affected count
6,535 tubes and bottles
Manufactured in
600 College Rd E Ste 2100, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-163-2013Don't want to check this manually?
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