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Recall Observatory FDA recall evidence

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

September 09, 2020

Class III

Product summary

Firm
P & L Developments, LLC
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing