Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.

FDA recall notice · announced February 20, 2013 · Ranbaxy

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: RB93911, Exp 07/14
Quantity: 4,016 bottles
Status: Terminated
Products in this recall event:
- 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. (D-163-2013)
- Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14. (D-162-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.