FDA Drug recall D-1489-2014
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS…
- FDA Drug
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS… by Dermamedics, citing marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1489-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-10 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dermamedics |
| Distribution | US |
Product
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Identifiers
| code_info | all lot codes |
|---|
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-1489-2014%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.