Drug 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.
D-163-2013
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 64286
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,535 tubes and bottles
- Official record key
drug-enforcement:D-163-2013
Official wording
Reason: Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Code information: Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.