# FDA recall D-0004-2021

> **P & L Developments,  LLC** · Class III · drug recall initiated 2020-09-09.

## Product

Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA  17011, NDC 11822-3328-3.

## Reason for recall

Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.

## Distribution

Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-0004-2021
- **Recalling firm:** P & L Developments,  LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-09
- **Report date:** 2020-10-07
- **Termination date:** 2022-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2021

## Citation

> AI Analytics. FDA recall D-0004-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0004-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*