FDAFDA · Food and drugs·Recall number D-0004-2021
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.
Published October 7, 2020 · Recall initiated: September 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- P & L Developments, LLC
- Distributor
- Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
- Lot
- Lot # WJ04186, exp. date 01/23
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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