Why it was 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.
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.
Lot numbers, UPCs & expiration codes
Lot # WJ04186, exp. date 01/23
Where it was sold
Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0004-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 9, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- 4,752 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- P & L Developments, LLC
Original FDA data
Every field from FDA enforcement report D-0004-2021, exactly as published.
Show all FDA fields
- City
- Westbury
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86403
- Address
- 200 Hicks St
- Code information
- Lot # WJ04186, exp. date 01/23
- Postal code
- 11590-3323
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-0004-2021
- Classification
- Class III
- Recalling firm
- P & L Developments, LLC
- Product quantity
- 4,752 cartons
- Termination date
- Jan 21, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- 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.
- Recall initiation date
- Sep 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2020