Rite Aid Nicotine Gum Recalled for Incorrect Package Insert
P & L Developments is recalling 4,752 cartons of Rite Aid 2 mg nicotine gum because the package insert is for the Canadian market and not the approved US labeling.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (incorrect package insert) rather than a physical defect or contamination.
Plain-English summary
P & L Developments, LLC is recalling 4,752 cartons of Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton. The product is distributed by Rite Aid and carries NDC 11822-3328-3. The specific lot affected is # WJ04186 with an expiration date of 01/23.
The recall was initiated due to a labeling error. The package insert included in the finished product is intended for the Canadian market and is not part of the current approved drug labeling for the United States. This is classified as an FDA Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product was distributed to one retailer type in New York and Maryland, who may have further distributed the product throughout the United States. Consumers should check their cartons for the specific lot number and expiration date listed above. If the product matches these details, consumers should stop using it and contact the distributor or retailer for a refund or replacement.
The recalled product
- 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.
- Manufacturer
- P & L Developments, LLC
- Hazard
- Affected units
- 4,752
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # WJ04186
- exp. date 01/23
Distribution
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