Recalls / Class III
Class IIID-0004-2021
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.
- Affected lot / code info
- Lot # WJ04186, exp. date 01/23
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.
Recalling firm
- Firm
- P & L Developments, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Hicks St, N/A, Westbury, New York 11590-3323
Distribution
- Quantity
- 4,752 cartons
- 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.
Timeline
- Recall initiated
- 2020-09-09
- FDA classified
- 2020-10-01
- Posted by FDA
- 2020-10-07
- Terminated
- 2022-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0004-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.