FDA Drug recall D-163-2013
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28
- FDA Drug
- Class III
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class III recall of Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28 by Ranbaxy, citing crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-163-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-27 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ranbaxy |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-163-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.