The Recall Desk

FDA (Drugs) recall action 64286

Ranbaxy Inc. recalled 2 products on 2013-02-20

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-02-20
Critical
0
Units
10,551

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2013-02-20

    Ranbaxy Recalls Lac-Hydrin Cream Due to Crystallization

    Ranbaxy Inc. is recalling specific lots of Lac-Hydrin (ammonium lactate) Cream, 12%, due to a gritty texture caused by crystallization.

    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.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2013-02-20

    Ranbaxy Recalls Lac-Hydrin Lotion Due to Crystallization Texture

    Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin Lotion, 12%, due to a gritty texture caused by crystallization.

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