Nicotine Gum recall: Labeling Error
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.
Why was Nicotine Gum 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # WJ04186, exp. date 01/23
- 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.
- Recalling firm
- P & L Developments, LLC
- Quantity
- 4,752 cartons
- Distribution
- Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
- Recall date
- October 7, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)