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.
Reported: February 20, 2013 Initiated: December 27, 2012 #D-163-2013
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.
Details
- Recalling Firm
- Ranbaxy Inc.
- Units Affected
- 6,535 tubes and bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ranbaxy Inc.. Units affected: 6,535 tubes and bottles.
Why was this product recalled? ▼
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2013. Severity: Low. Recall number: D-163-2013.
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