D-0004-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- September 9, 2020
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,752 cartons
Product Description
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 Pattern
Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
Code Information
Lot # WJ04186, exp. date 01/23