FDA Drug recall 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 Hil…
- FDA Drug
- Class III
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class III recall of Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hil… by P And L Developments, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0004-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-09-09 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | P And L Developments |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot # WJ04186, exp. date 01/23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.