# FDA recall D-1381-2022

> **Family Dollar Stores, Llc.** · Class II · drug recall initiated 2022-06-23.

## Product

ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432   GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543   ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968   ORAJEL MOUTH SORE GEL 0.125 OZ	SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

## Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1381-2022
- **Recalling firm:** Family Dollar Stores, Llc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-06-23
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chesapeake, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2022

## Citation

> AI Analytics. FDA recall D-1381-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-1381-2022. Source: US FDA. Licensed CC0.

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