Drug 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.
D-0004-2021
Product summary
- Event
- Event 86403
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,752 cartons
- Official record key
drug-enforcement:D-0004-2021
Official wording
Reason: 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.
Code information: Lot # WJ04186, exp. date 01/23
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.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing