FDA DrugsClass III
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed...
Published: June 3, 2026Recall ID: D-0550-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Product Description & Identification
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Additional Source Details
| Field | Value |
|---|---|
| City | Miramar |
| State | FL |
| Openfda › Nui › 1 | N0000175706 |
| Openfda › Nui › 2 | M0014836 |
| Openfda › Unii | 6M3C89ZY6R |
| Openfda › Route | TRANSDERMAL |
| Openfda › Rxcui › 1 | 198029 |
| Openfda › Rxcui › 2 | 198030 |
| Openfda › Rxcui › 3 | 198031 |
| Openfda › Spl id | 1a266044-8837-71cc-e063-6394a90afcc0 |
| Openfda › Brand name | NICOTINE |
| Openfda › Spl set id | 2dd4cbda-5c46-4655-b69d-21b7d2e912cf |
| Openfda › Package ndc › 1 | 0536-5896-53 |
| Openfda › Package ndc › 2 | 0536-5896-88 |
| Openfda › Package ndc › 3 | 0536-5896-71 |
| Openfda › Package ndc › 4 | 0536-5895-53 |
| Openfda › Package ndc › 5 | 0536-5895-88 |
| Openfda › Package ndc › 6 | 0536-5895-71 |
| Openfda › Package ndc › 7 | 0536-5894-53 |
| Openfda › Package ndc › 8 | 0536-5894-88 |
| Openfda › Product ndc › 1 | 0536-5894 |
| Openfda › Product ndc › 2 | 0536-5896 |
| Openfda › Product ndc › 3 | 0536-5895 |
| Openfda › Generic name | NICOTINE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs | Nicotine [CS] |
| Openfda › Substance name | NICOTINE |
| Openfda › Pharm class epc | Cholinergic Nicotinic Agonist [EPC] |
| Openfda › Manufacturer name | Rugby Laboratories |
| Openfda › Application number | ANDA074612 |
| Openfda › Is original packager | true |
| Event id | 98972 |
| Address 1 | 3250 Commerce Pkwy |
| Code info | Lot #: 56841, Expires: 03/2028 |
| Postal code | 33025-3907 |
| Report date | 20260603 |
| Product type | Drugs |
| Product quantity | 59,808 pouches (4,272 Individual Folding Carton (IFC)) |
| Reason for recall | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260514 |
| Initial firm notification | Letter |
| Center classification date | 20260526 |
Overview
- Recalling FirmAVEVA Drug Delivery Systems, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the U.S