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.
FDA recall notice · announced October 7, 2020 · P & L Developments
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
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.
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.
Notes
Distribution: Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
Lot/code information: Lot # WJ04186, exp. date 01/23
Quantity: 4,752 cartons
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.