# FDA recall D-1489-2014

> **Dermamedics, L.L.C.** · Class II · drug recall initiated 2014-01-10.

## 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 for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1489-2014
- **Recalling firm:** Dermamedics, L.L.C.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-10
- **Report date:** 2014-08-06
- **Termination date:** 2017-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2014

## Citation

> AI Analytics. FDA recall D-1489-2014. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1489-2014. Source: US FDA. Licensed CC0.

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