September 2020 FDA Recall Drug by P & L Developments, Llc
D-0004-2021 - Labeling

This Class III drug recall was voluntarily initiated by P & L Developments, Llc on September 9, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0004-2021

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.
Initiated
09-09-2020
Reported
10-07-2020
Quantity
4,752 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86403
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
P & L Developments, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-21-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# WJ04186, exp. date 01/23