FDA recall D-0004-2021

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

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

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