P & L Developments, LLC recalls Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 H…

Recall date

September 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0004-2021

FDA classification

Class III

Brand / firm

P & L Developments, LLC

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.