Drug product
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
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 64286
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,016 bottles
- Official record key
drug-enforcement:D-162-2013
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 #: RB93911, Exp 07/14
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.